NRAC Issue #1702 ADDENDUM October 7, 2008 --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT Varian Medical Systems Eclipse device, model H48, Version 6.5 is used to plan photon and electron radiation therapy treatments RECALL NUMBER # Z-2308-2008 CODE H480001 H480341 H480738 H481107 H481548 H482157 H482608 H483158 H483809 H484524 H480003 H480345 H480740 H481108 H481553 H482158 H482609 H483159 H483818 H484535 H480004 H480348 H480749 H481114 H481554 H482159 H482611 H483161 H483820 H484539 H480009 H480351 H480753 H481115 H481556 H482160 H482624 H483164 H483821 H484540 H480012 H480355 H480754 H481116 H481558 H482162 H482625 H483180 H483823 H484544 H480017 H480356 H480756 H481133 H481559 H482163 H482630 H483181 H483830 H484553 H480019 H480357 H480762 H481135 H481567 H482166 H482634 H483191 H483835 H484603 H480022 H480358 H480764 H481141 H481571 H482173 H482638 H483207 H483840 H484610 H480025 H480367 H480766 H481142 H481572 H482178 H482641 H483224 H483843 H484617 H480026 H480371 H480773 H481143 H481573 H482179 H482645 H483244 H483847 H484634 H480030 H480373 H480775 H481163 H481585 H482189 H482648 H483253 H483852 H484639 H480032 H480375 H480776 H481180 H481588 H482198 H482662 H483254 H483858 H484640 H480040 H480382 H480779 H481195 H481597 H482199 H482664 H483255 H483869 H484641 H480042 H480385 H480781 H481196 H481599 H482203 H482671 H483270 H483915 H484643 H480043 H480404 H480794 H481197 H481601 H482204 H482681 H483275 H483916 H484650 H480049 H480411 H480798 H481198 H481602 H482205 H482683 H483277 H483942 H484657 H480050 H480416 H480810 H481205 H481605 H482215 H482691 H483312 H483943 H484658 H480056 H480417 H480814 H481206 H481607 H482225 H482697 H483315 H483970 H484673 H480063 H480418 H480816 H481213 H481609 H482228 H482698 H483317 H483973 H484677 H480067 H480420 H480817 H481226 H481618 H482243 H482704 H483322 H483975 H484680 H480068 H480421 H480820 H481229 H481625 H482244 H482709 H483325 H483984 H484681 H480072 H480432 H480821 H481232 H481627 H482247 H482714 H483328 H483987 H484684 H480073 H480443 H480827 H481239 H481631 H482256 H482715 H483341 H483988 H484695 H480075 H480445 H480830 H481250 H481632 H482264 H482726 H483345 H483991 H484698 H480078 H480455 H480833 H481252 H481641 H482273 H482762 H483355 H483994 H484699 H480095 H480458 H480839 H481257 H481647 H482274 H482763 H483356 H484002 H484706 H480102 H480459 H480852 H481259 H481661 H482283 H482770 H483363 H484003 H484744 H480104 H480461 H480855 H481262 H481678R1 H482284 H482773 H483370 H484010 H484752 H480105 H480462 H480861 H481279 H481681 H482285 H482791 H483371 H484015 H484757 H480108 H480464 H480868 H481285 H481692 H482286 H482796 H483373 H484024 H484770 H480109 H480470 H480873 H481286 H481696 H482288 H482799 H483381 H484031 H484781 H480116 H480478 H480876 H481289 H481698 H482292 H482801 H483384 H484049 H484788 H480117 H480483 H480886 H481294 H481702 H482295 H482803 H483396 H484052 H484839 H480123 H480485 H480891 H481297 H481711 H482327 H482815 H483410 H484053 H484844 H480128 H480486 H480893 H481299 H481715 H482369 H482817 H483424 H484057 H484846 H480129 H480488 H480894 H481312 H481716 H482372 H482818 H483427 H484077 H484856 H480131 H480496 H480896 H481315 H481717 H482374 H482824 H483431 H484083 H484861 H480138 H480500 H480897 H481318 H481718 H482380 H482826 H483434 H484085 H484864 H480140 H480510 H480906 H481319 H481724 H482381 H482832 H483449 H484087 H484873 H480141 H480513 H480907 H481326 H481727 H482389 H482835 H483453 H484099 H484910 H480142 H480530 H480908 H481330 H481748 H482390 H482842 H483459 H484105 H484911 H480151 H480533 H480916 H481334 H481751 H482401 H482844 H483463 H484121 H484912 H480152 H480535 H480923 H481338 H481754 H482403 H482849 H483465 H484124 H484960 H480172 H480536 H480927 H481340 H481758 H482408 H482853 H483466 H484128 H485041 H480174 H480537 H480930 H481341 H481765 H482411 H482856 H483477 H484135 H485053 H480183 H480539 H480933 H481344 H481767 H482418 H482865 H483495 H484144 H485079 H480185 H480542 H480937 H481345 H481768 H482420 H482870 H483496 H484149 H485083 H480186 H480543 H480945 H481352 H481770 H482436 H482871 H483500 H484155 H485113 H480190 H480547 H480946M H481357 H481771 H482438 H482876 H483506 H484160 H485114 H480199 H480549 H480946R1 H481358 H481791 H482439 H482882 H483509 H484161 H485135 H480200 H480554 H480951 H481361 H481797 H482440 H482888 H483525 H484163 H485183 H480201 H480573 H480953 H481364 H481800 H482442 H482890 H483531 H484170 H485188 H480207 H480577 H480958 H481374 H481802 H482448 H482897 H483532 H484174 H485209 H480211 H480587 H480961 H481376 H481803 H482450 H482915 H483535 H484175 H485219 H480212 H480588 H480963 H481377 H481810 H482456 H482921 H483538 H484177 H485268 H480217 H480589 H480964 H481378 H481818 H482460 H482926 H483555 H484180 H485269 H480219 H480596 H480967 H481384 H481824 H482461 H482928 H483557 H484185 H485271 H480220 H480599 H480968 H481389 H481825 H482473 H482941 H483558 H484221 H485276 H480222 H480601 H480970 H481391 H481834 H482484 H482946 H483587 H484228 H485279 H480233 H480606 H480971 H481393 H481837 H482485 H482964 H483591 H484254 H485288 H480238 H480608 H480973 H481401 H481840 H482487 H482982 H483592 H484257 H485311 H480239 H480611 H480974 H481406 H481849 H482489 H482988 H483595 H484258 H485333 H480244 H480615 H480976M H481420 H481857 H482492 H482989 H483602 H484269 H485365 H480245 H480617 H480976R1 H481421 H481859 H482493 H482992 H483606 H484274 H485371 H480247 H480619 H480983 H481423 H481861 H482502 H482993 H483615 H484277 H485389 H480248 H480622 H480985 H481426 H481862 H482506 H483001 H483616 H484280 H485399 H480250 H480626 H480989 H481429 H481880 H482508 H483002 H483619 H484286 H485430 H480265 H480639 H480992 H481431 H481881 H482519 H483010 H483632 H484287 H485453 H480266 H480645 H480993 H481432 H481892 H482520 H483012 H483639 H484321 H485457 H480278 H480651 H480994 H481435 H481893 H482521 H483024 H483646 H484324 H485471 H480281 H480653 H481006 H481436 H481896 H482522 H483028 H483647 H484333 H485520 H480283 H480657 H481011 H481442 H481897 H482531 H483029 H483650 H484337 H485547 H480286 H480658 H481014 H481446 H481900 H482539 H483040 H483654 H484340 H485558 H480289 H480659 H481022 H481448 H481901 H482540 H483042 H483670 H484347 H485569 H480295 H480661 H481041 H481467 H481910 H482544 H483057 H483675 H484348 H485592 H480301 H480662 H481043 H481475 H481911 H482545 H483063 H483679 H484351 H485596 H480305 H480671 H481054 H481486 H481918 H482556 H483088 H483686 H484367 H485628 H480307 H480691 H481058 H481487 H481921 H482561 H483091 H483688 H484371 H485658 H480309 H480692 H481060 H481489 H481927 H482562 H483095 H483690 H484374 H485684 H480311 H480694 H481062 H481493 H481936 H482564 H483103 H483691 H484375 H485692 H480316 H480698 H481063 H481494 H481939 H482566 H483106 H483697 H484383 H485693 H480319 H480702 H481066 H481503 H481940 H482571 H483115 H483706 H484386 H485695 H480321 H480704 H481070 H481504 H481952 H482572 H483117 H483717 H484388 H485696 H480323 H480714 H481071 H481507 H482114 H482578 H483123 H483749 H484421 H485719 H480329 H480717 H481074 H481513 H482120 H482586 H483134 H483750 H484437 H485721 H480333 H480718 H481077 H481515 H482121 H482587 H483138 H483751 H484467 H485846 H480336 H480722 H481079 H481526 H482124 H482590 H483143 H483755 H484476 H485853 H480340M H480726 H481088 H481530 H482125 H482593 H483151 H483757 H484497 H485943 H480340R1 H480727 H481104 H481535 H482129 H482594 H483153 H483767 H484509 H485995 H480732 H481106 H481544 H482151 H482603 H483154 H483803 H484513 H486114 H486135 H486209 H486214 H486250 H486403 H486434 H486657 and H486313 MANUFACTURED & RECALLED BY Varian Medical Systems Oncology Systems, Palo Alto, CA QUANTITY 907 units DISTRIBUTION Nationwide and Internationally REASON Software anomaly in which swapping IDs of planning fields can produce inconsistencies between dose matrix and field parameters. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT a) Zimmer Patient Helper Reinforced Overhead Bar for Hill-Rom beds with removable headboards; Prod. Nos. 00-0965-000-00 and 00-0965-001-00. The product is an L shaped bar that is used with hospital beds set up for traction. The bar allows mounting of a trapeze to help the patient pull themselves up when in the hospital bed RECALL NUMBER # Z-2296-2008 PRODUCT b) Zimmer Patient Helper Reinforce Overhead Bar for Hill-Rom Versa Care beds. Prod. Nos. 00-2700-965-02 and 00-0965-001-00. The product is an L shaped bar that is used with hospital beds set up for traction. The bar allows mounting of a trapeze to help the patient pull themselves up when in the hospital bed RECALL NUMBER # Z-2297-2008 PRODUCT c) Zimmer Freestanding Patient Helper for Hill-Rom Totalcare beds; Prod. Nos. 00-2700-965-00 and 00-0965-001-00. The product is a L shaped bar that is used with hospital beds set up for traction. The bar allows mounting of a trapeze to help the patient pull themselves up when in the hospital bed RECALL NUMBER # Z-2298-2008 CODE All units shipped between 7/11/07 and 5/19/08 MANUFACTURER Zimmer Orthopaedic Surgical Products, Dover, OH RECALLED BY Zimmer Inc., Warsaw, IN QUANTITY 645 units DISTRIBUTION Nationwide and Canada REASON If the bed is in the upright position and the bar is dropped rapidly or in free-fall, it could strike the patient in the bed, and the drop could present a laceration hazard by creating a sharp edge on the metal bar. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT a) Piccolo Chemistry Analyzer software version 6.121. Model Number 400-1028 in polyfoil pouch. Piccolo Comprehensive Metabolic Panel is a single-use self-contained reagent disk, intended for use with the Piccolo and PiccoloXpress chemistry analyzers, for in vitro qualitative determination. RECALL NUMBER # Z-2286-2008 PRODUCT b) Piccolo Chemistry Analyzer software version 6.121 with Electrolyte Panel, model number 400-1022 in polyfoil pouch. Piccolo Electrolyte Panel is a single-use, self-contained reagent disk intended for use with the Piccolo and PiccoloXpress chemistry analyzers, for in vitro qualitative determination RECALL NUMBER # Z-2287-2008 CODE a) Lot # 8111AA5, exp. date 2009-03-10 b) Lot # 8041AC5, exp. date 2009-01-21 MANUFACTURED & RECALLED BY Abaxis, Inc., Union City, CA QUANTITY 1,130 kits DISTRIBUTION Nationwide and Internationally REASON The product will recover tCO2 at approximately 5-7 units high relative to 03-10. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT Miller bone cement injector front loading cartridge kit, compatible with Zimmer vacuum mixing system, QTY - 10, sterile; Cat. No. 5069-52. The product is used for the injection of bone cement RECALL NUMBER # Z-2295-2008 CODE Lot # 60750536 MANUFACTURER Zimmer Orthopaedic Surgical Products, Dover, OH RECALLED BY Zimmer Inc., Warsaw, IN QUANTITY 257 packages of 10 kits each DISTRIBUTION Nationwide and Internationally REASON The cartridge is brittle and at increased risk of breakage. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT a) Hamilton Soft Grip Pipettes, 1 ml fixed volume, model number 55019-19. Product is indicated for manual pipetting. RECALL NUMBER # Z-2232-2008 PRODUCT b) Hamilton Soft Grip Pipettes, 1 ml adjustable volume, model number 55019-40. Product is indicated for manual pipetting. RECALL NUMBER # Z-2233-2008 CODE a) Serial numbers 64133, 64137, 64139, 64145, 64148, 64156, 64163, 64171, 64175, 4180, 64189, 64192, 64193, 64193, 64198, 64199, 64200, 64202, 64203, 64205, 64211, 64212, 64216, 64224, 64225, 64921, 65072, 65081, 65099, 65105, 65107, 65110, 65140, 65141, 65151, 65159, 65160, 65163, 65164, 65172, 65486, 65501, 65517, 65540, 65585, 65599, 65619, 65629, 65658, 65699, 65934, 65951, 65969, 65972, 65992, 66764, 66783, 66788, 66793, 66892, 66897, 66902, 66972, 66982, 66991, 66999, 67001, 67031, 67035, 67044, 67054, 67055, 67059, 67082, 67084, 67091, 67094, 67098, 67120, 67130, 67145, 67162, 67167, 67170, 67175, 67176, 67190, 67191, 67198, 67224, 67237, 67247, 67258, 67260, 67269, 67278, 67280, 67282, 67283, and 67285 b) Serial numbers 63045, 63098, 63135, 63157, 63208, 63248, 63278, 63378, 63401, 63418, 63421, 63442, 63461, 63485, 63524, 63527, 63590, 63679, 63753, 63788, 63804, 63820, 63825, 63834, 63836, 63848, 63857, 63885, 63892, 63904, 63951, 63989, 63993, 64047, 64057, 64074, 64076, 64093, 64140, 64160, 64242, 64246, 64261, 64279, 64288, 64289, 64314, 64342, 64352, 64362, 64399, 64407, 64427, 64478, 64479, 64480, 64492, 64498, 64504, 64507, 64518, 64520, 64525, 64527, 64528, 64537, 64538, 64543, 64544, 64563, 64577, 64582, 64585, 64587, 64590, 64592, 64599, 64612, 64628, 64631, 64635, 64636, 64644, 64667, 64678, 64694, 64695, 64703, 64706, 64718, 64720, 64722, 64723, 64729, 64740, 64753, 64757, 64759, 64760, 64763, 64767, 64772, 64778, 64785, 64787, 64789, 64792, 64797, 64801, 64810, 65015, 65016, 65018, 65067, 65068, 65071, 65076, 65078, 65079, 65080, 65083, 65090, 65091, 65109, 65119, 65186, 65204, 65224, 65262, 65269, 65290, 65514, 65536, 65541, 65564, 65566, 65567, 65568, 65575, 65576, 65578, 65583, 65590, 65591, 65597, 65600, 65603, 65608, 65609, 65610, 65612, 65614, 65617, 65622, 65623, 65626, 65628, 65631, 65632, 65635, 65644, 65650, 65655, 65657, 65662, 65678, 65692, 65701, 65705, 65707, 65726, 65747, 65771, 65772, 65773, 65777, 65836, 65858, 65906, 65910, 65916, 65917, 65918, 65921, 65925, 65926, 65927, 65929, 65930, 65933, 65935, 65936, 65938, 65946, 65947, 65952, 65953, 65959, 65961, 65964, 65966, 65973, 65979, 65981, 65982, 65983, 65987, 65993, 65995, 65996, 65997, 65998, 65999, 66000, 66002, 66007, 66008, 66013, 66014, 66015, 66016, 66017, 66019, 66062, 66079, 66088, 66104, 66107, 66115, 66124, 66138, 66145, 66174, 66182, 66196, 66197, 66198, 66201, 66205, 66210, 66222, 66226, 66233, 66252, 66253, 66270, 66286, 66289, 66296, 66305, 66309, 66341, 66342, 66345, 66351, 66353, 66361, 66366, 66372, 66373, 66380, 66397, 66398, 66400, 66402, 66403, 66404, 66417, 66418, 66422, 66423, 66425, 66426, 66431, 66434, 66436, 66438, 66443, 66444, 66448, 66450, 66452, 66453, 66456, 66463, 66465, 66474, 66475, 66480, 66483, 66484, 66488, 66490, 66496, 66497, 66503, 66504, 66505, 66512, 66517, 66519, 66520, 66522, 66523, 66534, 66535, 66538, 66540, 66548, 66549, 66550, 66552, 66555, 66556, 66557, 66558, 66560, 66562, 66565, 66567, 66568, 66569, 66573, 66574, 66576, 66577, 66578, 66582, 66584, 66591, 66601, 66603, 66605, 66607, and 66612 MANUFACTURED & RECALLED BY Hamilton Co., Reno, NV QUANTITY 353 units DISTRIBUTION Nationwide, PR, New Zealand, Australia, Japan and Canada REASON Manufacturing issue with spring may restrict product to drawing less than 1/2 of its stated measured capacity. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT a) Silhouette Xtraflo Device with SL-6 Hydrophilic Coating, Model Number: B3856, Size 6F x 24cm Urological stents are disposable single-use temporary indwelling catheters that allow urine to drain through obstructed or strictured ureters RECALL NUMBER # Z-2219-2008 PRODUCT b) Silhouette Xtraflo Device with SL-6 Hydrophilic Coating, Model Number: B3857, Size 6F x 26cm Urological stents are disposable single-use temporary indwelling catheters that allow urine to drain through obstructed or strictured ureters RECALL NUMBER # Z-2220-2008 PRODUCT c) Silhouette Xtraflo Device with SL-6 Hydrophilic Coating, Model Number: B3855, Size 6F x 22cm Urological stents are disposable single-use temporary indwelling catheters that allow urine to drain through obstructed or strictured ureters RECALL NUMBER # Z-2221-2008 PRODUCT d) Silhouette Xtraflo Device with SL-6 Hydrophilic Coating, Model Number: B3827, Size 6F multilength Urological stents are disposable single-use temporary indwelling catheters that allow urine to drain through obstructed or strictured ureters RECALL NUMBER # Z-2222-2008 PRODUCT e) Silhouette Xtraflo Device with SL-6 Hydrophilic Coating, Model Number: BS123, Size 6F multilength Urological stents are disposable sing-use temporary indwelling catheters that allow urine to drain through obstructed or strictured ureters RECALL NUMBER # Z-2223-2008 PRODUCT f) Silhouette Xtraflo Device with SL-6 Hydrophilic Coating, Model Number: B3957, Size 6F x 26cm Urological stents are disposable single-use temporary indwelling catheters that allow urine to drain through obstructed or strictured ureters RECALL NUMBER # Z-2224-2008 CODE a) Lot Numbers: 1058016, 1059244 and 1060923 b) Lot Number: 1059245 c) Lot Number: 1060602 d) Lot Number: 1060921 e) Lot Number: 1060921 and 1062602 f) Lot Numbers: 1060924 and 1062803 MANUFACTURED & RECALLED BY Applied Medical Resources, Corp., Rancho Santa Margarita, CA, QUANTITY 236 units DISTRIBUTION Nationwide, Australia and South Africa REASON Possible movement or dislodgement of the positioner marker band during use. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT a) Dynasty Trial Shell 62mm Group G, REF 3300-GG62, Rx only, Non-Sterile, 1 each, Orthopaedic instrument used for the preparation of the implant site prior to device implantation RECALL NUMBER # Z-2215-2008 PRODUCT b) Dynasty Trial Shell 64mm OD, Group H, REF 3300-GH64, Rx only, Non-Sterile, 1 each, Orthopaedic instrument used for the preparation of the implant site prior to device implantation RECALL NUMBER # Z-2216-2008 PRODUCT c) Dynasty Trial Shell 66mm OD, Group H, REF 3300-GH66, Rx only, Non-Sterile, 1 each. Orthopaedic instrument used for the preparation of the implant site prior to device implantation RECALL NUMBER # Z-2217-2008 PRODUCT d) Dynasty Trial Shell 68mm OD, Group H, REF 3300-GH68, Rx only, Non-Sterile, 1 each, Orthopaedic instrument used for the preparation of the implant site prior to device implantation RECALL NUMBER # Z-2218-2008 CODE a) and b) Lot Nos.: 037386983 and 117456822 c) and d) Lot Nos.: 037386983 and 117459853 MANUFACTURER Patterson Machine, Union Grove, AL RECALLED BY Wright Medical Technology Inc., Arlington, TN QUANTITY 509 units DISTRIBUTION Nationwide and Canada REASON Trials are 2.5 mm larger than marked. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT VectorVision (VV) Sky Navigation Platform (19Ó Computer Rack); The 19Ó computer rack is a component of the VVaky Vario, BrainSUITE iMRI, BrainSUITE NET and BrainSUITE iCT systems; Intended to be an intraoperative image guided localization system to enable minimally invasive surgery. Indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure can be identified to relative to a CT, CTA, X-ray, MR, MRA and ultrasound based model of the anatomy RECALL NUMBER # Z-2209-2008 CODE VVsky Art. No. 50945; all VVsky products with Data Billboards and/or microscope integrations and/or Device Connections Panels (Wall Panels) MANUFACTURED & RECALLED BY Bainlab AG, Kirchheim B. Muenchen, Germany QUANTITY 23 units DISTRIBUTION Nationwide REASON Diameter of cables used for installation is too small for the applied current. If an internal short circuit is produced the medical power supply will not shut down automatically and will continue to deliver current, which could result in overheating cables. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT Surgical Table Column Casing Revision B, Product #0788-200-001 Revision B; component of Stryker's VERTIER Surgical Table. The tables are AC-powered or air-powered devices intended for use during diagnostic examination or surgical procedures to support the patient RECALL NUMBER # Z-2189-2008 CODE Lot/Serial #:070119-24045; 070119-24043; 070202-25062; 070319-27231; 070319-27232; 070202-25058; 071026-39230; 071026-39232; 070216-25279; 071019-38649 MANUFACTURER Merivaara Corp., Lahti, Finland RECALLED BY Stryker Communications Corp., Flower Mound, TX QUANTITY 10 units DISTRIBUTION CA, CO, TX and UT REASON Potential exists for energy chain, which is responsible for protecting hydraulic and electrical cables during up and down motion on VERTIER Surgical Table, to become lodged between column case sections resulting in possible reduction or lose of function to hand and/or foot controls or possible involuntary movement of the table. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT GE Centricity AW Suite software version 2.0 and 2.0.1 with Card IQ Xpress Pro or Plus Module; for diagnostic image analysis RECALL NUMBER # Z-2183-2008 CODE Software version 2.0 and 2.0.1 with Card IQ Module MANUFACTURED & RECALLED BY GE Healthcare Integrated IT Solutions, Barrington, IL QUANTITY 207 units DISTRIBUTION Nationwide and Internationally REASON When using any vessel analysis protocol of the AW Suite Card IQ application, the software can reload saved tracking objects (Save State) incorrectly and display an incorrect vessel label over the restored images. This failure only occurs when users create a custom label in the vessel analysis protocol and include leading or trailing blank characters (space bar) in the custom label. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT a) VisuaLine Single Dip Oxycodone; intended for in vitro immunoassay test completed by visual color comparison used for the detection of drugs of abuse. Sun Biomedical Part Number: 15-2016 RECALL NUMBER # Z-1873-2008 PRODUCT b) VisuaLine Propoxyphene; Propoxyphene test system, intended for in vitro immunoassay test completed by visual color comparison used for the detection of drugs of abuse. Sun Biomedical Part Number: 15-2017 RECALL NUMBER # Z-1874-2008 PRODUCT c) VisuaLine Tricyclic Antidepressants: Six Dip (COC-THC-OPI-MET-BZD-OXD); Six Dip (COC-THC-OPI-MET-PCP-OXD); Eight DIP (COC-THC-OPI-MET-AMP-BAR-BZD-OXD); Nine Dip (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-TCA); Ten Dip X (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-MTD-TCA); Ten Dip (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-MTD-OXD); Ten Dip (COC-THC- OPI-MET-PCP-AMP-BAR-BZD-TCA-OXD); Five Dip (COC-THC-OPI-BZD- OXD); and Six Dip (CPC-THC-OPI-MET-AMP-OXD). Product is intended for in vitro immunoassay test completed by visual color comparison used for the detection of drugs of abuse. Sun Biomedical 1) Part 15-2043; 2) Part 15-2046; 3) Part 15-2065; 4) Part 15-2072; 5) Part 15-2080; 6) Part 15-2083; 7) Part 15-2085; 8) Part 15-2095; and 9) Part 15-2101 RECALL NUMBER # Z-1875-2008 CODE a) Lot number Vis-OXD-dip 07-018-1-275 or Vis OXD-Dip 07-081-257 b) Lot number: Vis-PPX Dip 07-094-1-85 c) 1) Lot: Vis-6SP-Dip 08-021-1; 2) Lot: Vis-6SP-Dip 07-270-1; 3) Lot: Vis-8SP-Dip-07-207-2; 4) Lot: Vis-9SP-Dip-07-106-1; 5) Lot: Vis-10 Dip 06-204-2, Vis-10 Dip 07-002-2, Vis-10-Dip-07-231-1; 6) Lot: Vis-10SP-Dip-07-311-1; Vis-10SP-Dip 07-324-1, VIS 10SP-Dip-08-045-3; 7) Lot: Vis 10SP Dip-07-201-1, Vis-10SP-Dip 07-263-1; 8) Lot: Vis 5SP-Dip 07-284-2; Vis 5SP-Dip -8-008-01; 9) Lot: Vis-6SP Dip-07-326-1 MANUFACTURED & RECALLED BY Sun Biomedical Laboratories, Inc., Blackwood, NJ QUANTITY 1,137 units DISTRIBUTION Nationwide REASON Product was sold while the devices were under FDA 510 (k) review, which was subsequently denied. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT X-STOP Interspinous Process Decompression (IPD) System, (With Physician's Guide, P/N 16000789-01 (Ti device), P/N 16001013-01 (PEEK device); Catalog numbers for X-STOP Titanium Implant: 1-2206 US 6MM X-STOP, 1-2208 US 8MM X-STOP, 1-2210 US 10MM X-STOP, 1-2212 US 12MM X-STOP, 1-2214 US 14MM X-STOP. Catalog numbers include for X-STOP PEEK Implant: 1-3206 US 6mm X STOPpk, 1-3208 US 8mm X STOPpk, 1-3210 US 10mm X STOPpk, 1-3212 US 12mm X STOPpk, 1-3214 US 14mm X STOPpk, 1-3216 US 16mm X STOPpk. Spinal implants RECALL NUMBER # Z-1765-2008 CODE All units MANUFACTURED & RECALLED BY Kyphon, Inc., Sunnyvale, CA QUANTITY Approximately 25,000 manuals distributed in the US DISTRIBUTION Nationwide and Internationally REASON Physician instructions revised due to product breakage: during the implantation of the X-STOP IPD Device, the product has the potential to cause damage to and/or breakage of the X-STOP IPD Device's universal wing assembly. This includes the potential for breakage of the wing screw. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT a) Mevatron KD-2 Digital Linear Accelerator, part number 8515520 equipped with a Digital Electron Variable Applicator (DEVA, Part Number 8485971) with available energy of 6 MeV. Medical charged- particle radiation therapy system RECALL NUMBER # Z-1753-2008 PRODUCT b) Mevatron KDS-2 Digital Linear Accelerator, part number 9411588 equipped with a Digital Electron Variable Applicator (DEVA, Part Number 8485971) with available energy of 6 MeV. Medical charged- particle radiation therapy system RECALL NUMBER # Z-1754-2008 PRODUCT c) Mevatron KD-2 Digital Linear Accelerator, part number 9822685 equipped with a Digital Electron Variable Applicator (DEVA, Part Number 8485971) with available energy of 6 MeV. Medical charged- particle radiation therapy system RECALL NUMBER # Z-1755-2008 PRODUCT d) Mevatron KDS-2 Digital Linear Accelerator, part number 9822693 equipped with a Digital Electron Variable Applicator (DEVA, Part Number 8485971) with available energy of 6 MeV. Medical charged- particle radiation therapy system RECALL NUMBER # Z-1756-2008 PRODUCT e) Mevatron KD2 Digital Linear Accelerator, part number 1940753 equipped with a Digital Electron Variable Applicator (DEVA, Part Number 8485971) with available energy of 6 MeV RECALL NUMBER # Z-1757-2008 PRODUCT f) Mevatron M2/ Primus Mid Digital Linear Accelerator, part number 1940035 equipped with a Digital Electron Variable Applicator (DEVA, Part Number 8485971) with available energy of 6 MeV RECALL NUMBER # Z-1758-2008 PRODUCT g) PRIMUS Plus Digital Linear Accelerator, part number 4504200 equipped with a Digital Electron Variable Applicator (DEVA, Part Number 8485971) with available energy of 6 MeV RECALL NUMBER # Z-1759-2008 PRODUCT h) ONCOR IMPRESSION Plus Digital Linear Accelerator, part number 5857912 equipped with a Digital Electron Variable Applicator (DEVA, Part Number 8485971) with available energy of 6 MeV RECALL NUMBER # Z-1760-2008 PRODUCT i) MEVATRON M2-6740 part number 9401407equipped with a Digital Electron Variable Applicator (DEVA, Part Number 8485971) with available energy of 6 MeV RECALL NUMBER # Z-1761-2008 PRODUCT j) MEVATRON M2-6740 part number 9401506 equipped with a Digital Electron Variable Applicator (DEVA, Part Number 8485971) with available energy of 6 MeV RECALL NUMBER # Z-1762-2008 PRODUCT k) MEVATRON MD-2 part number 9401654 equipped with a Digital Electron Variable Applicator (DEVA, Part Number 8485971) with available energy of 6 MeV RECALL NUMBER # Z-1763-2008 CODE a) Serial numbers: 1938 and 2074 b) Serial number: 2084 c) Serial numbers: 2348, 2224, 2431, 2131, and 2405 d) Serial numbers: 2348 2224 2431 2131, and 2405 e) Serial numbers: 3041 2451 2525 2547 2575 2582 2589 2602 2667 2726 2769 2781 2801 2952, and 2571 f) Serial numbers: 3061 3986 2469 2476 2443 2455 2549 2719 2728 2772 2795 2821 2925 2999 3056 3083 3088 3169 3282 3325 3429 3432 3472 3538 3555 3563 3593 3633 3637 3682 3685 3726 3971 4007 5055 3923 2707 3321, and 2449 g) Serial Numbers:3174 3241 3254 2938 3193 3359 3488 3529 3536 3717 3813 3844 3876 3985 3991 4033 4047 2782 2783 2785 2797 2815 2832 2862 2878 2904 2916 2918 2922 2942 2964 2973 2979 2989 2992 2993 2994 3007 3031 3043 3044 3046 3106 3117 3144 3183 3234 3242 3249 3262 3278 3284 3299 3308 3326 3334 3373 3389 3396 3408 3421 3431 3438 3455 3475 3481 3531 3561 3594 3632 3642 3689 3724 3728 3762 3767 3782 3814 3833 3867 3915 4004 4045 4051 4131 4232 5007 3431 3158 3216 3356, and 3619 h) Serial Number: 3894 i) Serial number: 2428 j) Serial Numbers 2355 and 2417 k) Serial numbers 2205, 2305, 2362, and 2425 MANUFACTURED & RECALLED BY Siemens Medical Solutions USA, Inc., Concord, CA QUANTITY 168 units DISTRIBUTION Nationwide and Internationally REASON Radiation leak: when used with field sizes of 5cm x 5cm or smaller, product may leak radiation at a distance of 2 cm from the side of the applicator body up to 13%, in excess of IEC standards. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT a) Toshiba America Medical Systems (TAMS) Aquilion 32 CT system, computed tomography x-ray system RECALL NUMBER # Z-1707-2008 PRODUCT b) Toshiba America Medical Systems (TAMS) Aquilion 64 CT system, computed tomography x-ray system RECALL NUMBER # Z-1708-2008 CODE All codes MANUFACTURED & RECALLED BY Toshiba American Medical Systems, Inc., Tustin, CA QUANTITY 1203 units DISTRIBUTION Nationwide and Japan REASON Excessive radiation: Intermittent shifting of CT numbers causes the actual dose to the patient to be greater than expected, when Sure Exposure option is used. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT Siemens Medical Solutions, syngo Dynamics 6.0 Workplace; Picture archiving and communication system RECALL NUMBER # Z-1751-2008 CODE All units with version 6.0 software MANUFACTURED & RECALLED BY Siemens Medical Solutions USA, Inc., Ann Arbor, MI QUANTITY 16 units DISTRIBUTION Nationwide REASON Incorrect data: a software bug may result in a transfer of patient demographic data to a different patientÕs file. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT Eclipse Treatment Planning System, Client 8.1.18 and DCF 8.1.17, model number H48 RECALL NUMBER # Z-1612-2008 CODE Serial numbers all starting with H48 (model number): 6509, 6974, 6616, 6688, 6806, 6568, 6530, 6839, 6740, 7178, 6700, 6694, 6505, 6924, 6979, 6715, 6556, 6757, 6820, 6545, 6564, 7027, 6783, 6553, 6760, 6904, 6907, 7037, 6639, 7088, 6702, 6659, 6940, 6802, 6856, 6944, 6841, 6870, 6874, 6928, 6913, 6614, 7009, 6951, 6493, 6758, 7030, 6453, 6704, 6555, 6691, 6914, 6739, 6846, 6685, 6473, 7015, 6875, 6566, 6599, 6818, 7020, 6799, 6804, 6699, 7075, 6901, 6827, 6833, 6681, 6724, 6499, 6698, 6722, 7018, 6782, 6893, 6522, 6937, 6708, 6560, 6977, 6978, 6803, 6961, 6503, 6814, 7029, 6707, 6686 MANUFACTURER Varian Medical Systems, Finland 04, Helsinki, Finland RECALLED BY Varian Medical Systems Oncology Systems, Palo Alto, CA QUANTITY 90 units DISTRIBUTION Nationwide and Internationally REASON A software error causes the wedge accessory calculation to be ignored in the radiotherapy treatment plan. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT a) ev3 55442-2920, sterile EO, single Use, Visi-Pro Balloon-Expandable Peripheral Stent System. Model Numbers: PXB35-05-12-080, PXB35-06-17-135, PXB35-06-27-080, PXB35-06-57-135, PXB35-07-37-080, PXB35-07-57-080, PXB35-08-17- 080, PXB35-08-17-135, PXB35-08-37-080, PXB35-08-57-080, PXB35-09-17-135, PXB35-09-27-080, PXB35-09-27-135, PXB35-09-57-080, PXB35-10-27-135, and PXB35-10-37-080 RECALL NUMBER # Z-1547-2008 PRODUCT b) ev3 sterile EO, single Use, Visi-Pro Balloon-Expandable Biliary Stent System. Model Numbers: PXB35-06-27-135, PXB35-06-37-080, PXB35-07-37-080, PXB35-08-17-080, PXB35-08-27- 135, PXB35-08-37-135, PXB35-08-57-080, and PXB35-09-17-135 4800 RECALL NUMBER # Z-1548-2008 CODE a) Lot Numbers: 3273766, 3273767, 3509137, 4218926, 4361370, 4472112, 4941116, 5012047, 5282885, and 5834997 b) Lot Numbers: 4089374, 4140341, 4151887, 4194358, 4239470, 4251836, 4484043, 44804047, 4491290, 4933989, 5005731, 5012045, 5045725, 5117532, 5147416, 5149205, 5214432, 5221941, 5239429, and 5577902 MANUFACTURED & RECALLED BY ev3, Inc, Plymouth, MN QUANTITY 278 units DISTRIBUTION Nationwide and Internationally REASON Specific lots of the Visi-Pro BE Stent system may not have adequate securement of the stent to the delivery system and may have a larger diameter/profile than intended. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT a) GE Healthcare Innova 3100 Digital Fluoroscopic Imaging System with Bolus Chasing option RECALL NUMBER # Z-1516-2008; PRODUCT b) GE Healthcare Innova 4100 Digital Fluoroscopic Imaging System with Bolus Chasing option RECALL NUMBER # Z-1517-2008 CODE a) 8613100, 77573841, 0910064009, 3018774100, 4103323100, 4103374100, 4103623100, 4105434100, 4438494100, 5138534100, 5703214100, 7083333100, 7278253100, 8019643100, 8595724100, 9408984100, 082416040017, 082416070004, 082416120006, 082416130013, 082416140003, 201541LAB2, 229228INNOV41V, 239436CATH1, 251435ICV5, 270688INN, 304255INNOVA, 304347INNOVA, 309691P3100, 310423INNOVA1, 313593IC1, 313593IC2, 314525SACL2, 315448RM4, 315448RM5, 316268INNOVAA, 319338VA4100, 325670CATH, 334286BSP, 352333VASC, 352376SP, 352401CATH, 352401VASC, 378INV31, 407SPECIALS, 409899LAB3, 413447CATH, 414961INN4100, 416756INNOVA, 417269SCLD, 478633INOV, 502587LAB4, 508856OR41, 516562INNOVA4, 516663INNOVA2, 518525LAB1, 540953INNOVA, 561266IN31, 563421CATHLAB8, 573632CRA, 573761SMA, 573815BCR1, 574535IN41, 574647IN41, 6012884100SP1, 601553CL3, 602239LAB4, 602239LAB6, 603778ECL1, 606833INNOVA, 614293LIBERTY1, 614293LIBERTY2, 615338CV2, 615769SKYCV2, 619340VA8, 619482INNOVA1, 619541INNOVA31, 619552INNOVA1, 626359INNOVA, 702616INNOVA, 7028803100A, 706774CCL5, 713794LAB7, 713794LAB9, 715369INN4100, 717217INN31, 717763INNOVA41, 717763OR4100, 718283INNOVA3, 718518CVL1, 724656ANG, 724773C1, 727725SPEC1, 731422CV1, 732294INOV, 757398INNOVA, 757736INNOVA, 765453INNOVA1, 770991CL3, 773792CL3100, 773NORWG3100, 803329CL31, 803329CL41, 804594CATH, 808547QCV2A, 812238LIB1, 812279INNOVA1, 812283IN31, 812450EP1, 812482INNOVA, 813972INTV, 816276SP1, 817255NH4100, 817433HSW3100, 83INNOVA1188379, 845365V19, 850678IN3100, 865541CCL5, 865693CCL3, 901726SP2, 903CSM4100, 904202CATH3, 904276SP, 908522LAB1, 909788INNOVA1, 918307SHIN4, 918744JC4100, 928779INNOVA1, 936266CL1, 956389INN31, 956632INN4100, 956994INN1, 956994INN2, 972487ANGIO1, 973971LAB3, BPINNOVA2, BPINNOVA3R, BPINNOVA3R, ECXV1406C, FHORLCL1, HC1536XR04, RU1550VA01, RU2457VA01, SLIN4100, YV0022, and YV0036 b) 8613100, 77573841, 0910064009, 3018774100, 4103323100, 4103374100, 4103623100, 4105434100, 4438494100, 5138534100, 5703214100, 7083333100, 7278253100, 8019643100, 8595724100, 9408984100, 082416040017, 082416070004, 082416120006, 082416130013, 082416140003, 201541LAB2, 229228INNOV41V, 239436CATH1, 251435ICV5, 270688INN, 304255INNOVA, 304347INNOVA, 309691P3100, 310423INNOVA1, 313593IC1, 313593IC2, 314525SACL2, 315448RM4, 315448RM5, 316268INNOVAA, 319338VA4100, 325670CATH, 334286BSP, 352333VASC, 352376SP, 352401CATH, 352401VASC, 378INV31, 407SPECIALS, 409899LAB3, 413447CATH, 414961INN4100, 416756INNOVA, 417269SCLD, 478633INOV, 502587LAB4, 508856OR41, 516562INNOVA4, 516663INNOVA2, 518525LAB1, 540953INNOVA, 561266IN31, 563421CATHLAB8, 573632CRA, 573761SMA, 573815BCR1, 574535IN41, 574647IN41, 6012884100SP1, 601553CL3, 602239LAB4, 602239LAB6, 603778ECL1, 606833INNOVA, 614293LIBERTY1, 614293LIBERTY2, 615338CV2, 615769SKYCV2, 619340VA8, 619482INNOVA1, 619541INNOVA31, 619552INNOVA1, 626359INNOVA, 702616INNOVA, 7028803100A, 706774CCL5, 713794LAB7, 713794LAB9, 715369INN4100, 717217INN31, 717763INNOVA41, 717763OR4100, 718283INNOVA3, 718518CVL1, 724656ANG, 724773C1, 727725SPEC1, 731422CV1, 732294INOV, 757398INNOVA, 757736INNOVA, 765453INNOVA1, 770991CL3, 773792CL3100, 773NORWG3100, 803329CL31, 803329CL41, 804594CATH, 808547QCV2A, 812238LIB1, 812279INNOVA1, 812283IN31, 812450EP1, 812482INNOVA, 813972INTV, 816276SP1, 817255NH4100, 817433HSW3100, 83INNOVA1188379, 845365V19, 850678IN3100, 865541CCL5, 865693CCL3, 901726SP2, 903CSM4100, 904202CATH3, 904276SP, 908522LAB1, 909788INNOVA1, 918307SHIN4, 918744JC4100, 928779INNOVA1, 936266CL1, 956389INN31, 956632INN4100, 956994INN1, 956994INN2, 972487ANGIO1, 973971LAB3, BPINNOVA2, BPINNOVA3R, BPINNOVA3R, ECXV1406C, FHORLCL1, HC1536XR04, RU1550VA01, RU2457VA01, SLIN4100, YV0022, and YV0036 MANUFACTURER GE Medical Systems, SCS, Buc Cedex, France RECALLED BY GE Healthcare, Waukesha, WI QUANTITY 146 units DISTRIBUTION Nationwide and Internationally REASON Incorrect dose data: After 6 days and 4 hours without performing a system reset or a system reboot (turning it off/on), the displayed dose data on these systems (Innova 3100 / Innova 4100 with Bolus option) may be underestimated by up to 50%. In order to avoid this issue, it is necessary to perform a system reset or reboot every day. GE Healthcare is working on a correction that will be installed on affected units. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT GE Healthcare OEC 9900 mobile fluoroscopic x-ray system RECALL NUMBER # Z-0368-2008 CODE All codes MANUFACTURED & RECALLED BY OEC Medical Systems, Inc., Salt Lake City, UT QUANTITY 710 units DISTRIBUTION Nationwide and Internationally REASON Possible overexposure: Failure to apply the entrance exposure rate (EER) tube current limit calibration to the automatic exposure rate (AER) control system when the anatomical profile mode is changed from the default selection to another selection. Manual technique modes are not affected. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT Ampicillin and Sulbactam for injection, USP, Pharmacy Bulk Package, Not for Direct Infusion, NOVAPLUS; NDC # 10019-638-03 RECALL NUMBER # D-377-2008 CODE Lot #: P2168, Exp. December 2009 MANUFACTURER G. C. Hanford Manufacturing Co., Syracuse, NY RECALLED BY Baxter Healthcare Corp., Round Lake, IL QUANTITY 4,197 vials DISTRIBUTION Nationwide REASON Presence of Particulate Matter. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT Strovite Tablets, 100 Tablet bottles, Rx only, NDC 00642-0200-10 RECALL NUMBER # D-376-2008 CODE Lot # 60904A2, Exp. 10/08; 70184A1, Exp. 2/09; 70923A2, Exp. 10/09 MANUFACTURER Actavis Totowa LLC, Totowa, NJ RECALLED BY Everett Laboratories, Inc., West Orange, NJ QUANTITY 11,820 bottles x 100 tablets DISTRIBUTION Nationwide REASON cGMP Deviation; Lack of stability indicating methods by manufacturer. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT 1) Cannon Catheter II, Long-Term Access. Catheter Length, Cuff to Tip: 19cm, CS-15242, Intended for single use only, Sterile, Rx only. The product is used for long term hemodialysis vascular access RECALL NUMBER # Z-2242-2008 PRODUCT 2) Cannon Catheter II, Long-Term Access. Catheter Length, Cuff to Tip: 23cm, CS-15282, Intended for single use only, Sterile, Rx only. The product is used for long term hemodialysis vascular access RECALL NUMBER # Z-2243-2008; PRODUCT 3) Cannon Catheter II, Long-Term Access. Catheter Length, Cuff to Tip: 27cm, CS-15322, Intended for single use only, Sterile, Rx only. The product is used for long term hemodialysis vascular access RECALL NUMBER # Z-2244-2008 PRODUCT 4) Cannon Catheter II, Long-Term Access. Catheter Length, Cuff to Tip: 31cm, CS-15362, Intended for single use only, Sterile, Rx only. The product is used for long term hemodialysis vascular access RECALL NUMBER # Z-2245-200 PRODUCT 5) Cannon Catheter" II, Long-Term Access. Catheter Length, Cuff to Tip: 50cm, CS-15552, Intended for single use only, Sterile, Rx only. The product is used for long term hemodialysis vascular access RECALL NUMBER # Z-2246-2008 PRODUCT 6) Cannon Catheter II, Long-Term Access. Catheter Length, Cuff to Tip: 19cm, CSD-15242, Intended for single use only, Sterile, Rx only. The product is used for long term hemodialysis vascular access RECALL NUMBER # Z-2247-2008 PRODUCT 7) Cannon Catheter II, Long-Term Access. Catheter Length, Cuff to Tip: 23cm, CSD-15282, Intended for single use only, Sterile, Rx only. The product is used for long term hemodialysis vascular access RECALL NUMBER # Z-2248-2008 PRODUCT 8) Cannon Catheter II, Long-Term Access. Catheter Length, Cuff to Tip: 27cm, CSD-15322, Intended for single use only, Sterile, Rx only. The product is used for long term hemodialysis vascular access RECALL NUMBER # Z-2249-2008 PRODUCT 9) Cannon Catheter II, Long-Term Access. Catheter Length, Cuff to Tip: 31cm, CSD-15362, Intended for single use only, Sterile, Rx only, The product is used for long term hemodialysis vascular access RECALL NUMBER # Z-2250-2008 PRODUCT 10) Cannon Catheter II, Long-Term Access. Catheter Length, Cuff to Tip: 50cm, CSD-15552, Intended for single use only, Sterile, Rx only. The product is used for long term hemodialysis vascular access RECALL NUMBER # Z-2251-2008 PRODUCT 11) Cannon II Plus, Long-Term Access. Catheter Length, Cuff to Tip: 19cm, CS-15242-SP, Intended for single use only, Sterile, Rx only. The product is used for long term hemodialysis vascular access RECALL NUMBER # Z-2252-2008 PRODUCT 12) Cannon II Plus, Long-Term Access. Catheter Length, Cuff to Tip: 23cm, CS-15282-SP, Intended for single use only, Sterile, Rx only. The product is used for long term hemodialysis vascular access RECALL NUMBER # Z-2253-2008 PRODUCT 13) Cannon II Plus, Long-Term Access. Catheter Length, Cuff to Tip: 27cm, CS-15322-SP, Intended for single use only, Sterile, Rx only. The product is used for long term hemodialysis vascular access RECALL NUMBER # Z-2254-2008 PRODUCT 14) Cannon II Plus, Long-Term Access. Catheter Length, Cuff to Tip: 31cm, CS-15362-SP, Intended for single use only, Sterile, Rx only. The product is used for long term hemodialysis vascular access RECALL NUMBER # Z-2255-2008 PRODUCT 15) Cannon II Plus, Long-Term Access. Catheter Length, Cuff to Tip: 50cm, CS-15552-SP, Intended for single use only, Sterile, Rx only. Road, The product is used for long term hemodialysis vascular access RECALL NUMBER # Z-2256-2008 PRODUCT 16) Cannon II Plus, Long-Term Access. Catheter Length, Cuff to Tip: 19cm, CS-15242-VSP, Intended for single use only, Sterile, Rx only. The product is used for long term hemodialysis vascular access RECALL NUMBER # Z-2257-2008 PRODUCT 17) Cannon II Plus, Long-Term Access. Catheter Length, Cuff to Tip: 23cm, CS-15282-VSP, Intended for single use only, Sterile, Rx only. The product is used for long term hemodialysis vascular access RECALL NUMBER # Z-2258-2008 PRODUCT 18) Cannon II Plus, Long-Term Access. Catheter Length, Cuff to Tip: 27cm, CS-15322-VSP, Intended for single use only, Sterile, Rx only. The product is used for long term hemodialysis vascular access RECALL NUMBER # Z-2259-2008 PRODUCT 19) Cannon II Plus, Long-Term Access. Catheter Length, Cuff to Tip: 31cm, CS-15362-VSP, Intended for single use only, Sterile, Rx only. The product is used for long term hemodialysis vascular access RECALL NUMBER # Z-2260-2008 PRODUCT 20) Cannon II Plus, Long-Term Access. Catheter Length, Cuff to Tip: 50cm, CS-15552-VSP, Intended for single use only, Sterile, Rx only. The product is used for long term hemodialysis vascular access RECALL NUMBER # Z-2261-2008 PRODUCT 21) Cannon II Plus, Hemodialysis Catherization Set, Long-Term Access. Catheter Length, Cuff to Tip: 19cm, CSD-15242-SP, Intended for single use only, Sterile, Rx only. The product is used for long term hemodialysis vascular access RECALL NUMBER #Z-2262-2008 PRODUCT 22) Cannon II Plus, Hemodialysis Catherization Set, Long-Term Access. Catheter Length, Cuff to Tip: 23cm, CSD-15282-SP, Intended for single use only, Sterile, Rx only. The product is used for long term hemodialysis vascular access RECALL NUMBER # Z-2263-2008 PRODUCT 23) Cannon II Plus, Hemodialysis Catherization Set, Long-Term Access. Catheter Length, Cuff to Tip: 27cm, CSD-15322-SP, Intended for single use only, Sterile RECALL NUMBER # Z-2264-2008 PRODUCT 24) Cannon II Plus, Hemodialysis Catherization Set, Long-Term Access. Catheter Length, Cuff to Tip: 31cm, CSD-15362-SP, Intended for single use only, Sterile, Rx only. The product is used for long term hemodialysis vascular access RECALL NUMBER # Z-2265-2008 PRODUCT 25) Cannon II Plus, Hemodialysis Catherization Set, Long-Term Access. Catheter Length, Cuff to Tip: 50cm, CSD-15552-SP, Intended for single use only, Sterile, Rx only. The product is used for long term hemodialysis vascular access RECALL NUMBER # Z-2266-2008 PRODUCT 26) Cannon II Plus, Hemodialysis Catherization Set with Arrow Simplicity, Long-Term Access, Cuff to Tip: 19cm, CS-15242-SPM, Intended for single use only, Sterile, Rx only. The product is used for long term hemodialysis vascular access RECALL NUMBER # Z-2267-2008 PRODUCT 27) Cannon II Plus, Hemodialysis Catherization Set with Arrow Simplicity, Long-Term Access, Cuff to Tip: 23cm, CS-15282-SPM, Intended for single use only, Sterile, Rx only. The product is used for long term hemodialysis vascular access RECALL NUMBER # Z-2268-2008 PRODUCT 28) Cannon II Plus, Hemodialysis Catherization Set with Arrow Simplicity", Long-Term Access, Cuff to Tip: 27cm, CS-15322-SPM, Intended for single use only, Sterile, Rx only. The product is used for long term hemodialysis vascular access RECALL NUMBER # Z-2269-2008 PRODUCT 29) Cannon II Plus, Hemodialysis Catherization Set with Arrow Simplicity, Long-Term Access, Cuff to Tip: 31cm, CS-15362-SPM, Intended for single use only, Sterile, Rx only. The product is used for long term hemodialysis vascular access RECALL NUMBER # Z-2270-2008 PRODUCT 30) ARROW Edge Hemodialysis Catherization Set with Arrow Simplicity, Long-Term Access, Cuff to Tip: 19cm, CS-15242-IM, Intended for single use only, Sterile, Rx only. The product is used for long term hemodialysis vascular access RECALL NUMBER # Z-2271-2008 PRODUCT 31) ARROW Edge Hemodialysis Catherization Set with Arrow Simplicity, Long-Term Access, Cuff to Tip: 23cm, CS-15282-IM, Intended for single use only, Sterile, Rx only. The product is used for long term hemodialysis vascular access RECALL NUMBER # Z-2272-2008 PRODUCT 32) ARROW Edge Hemodialysis Catherization Set with Arrow Simplicity, Long-Term Access, Cuff to Tip: 27cm, CS-15322-IM, Intended for single use only, Sterile, Rx only. The product is used for long term hemodialysis vascular access RECALL NUMBER # Z-2273-200 PRODUCT 33) ARROW EdgeÇ Hemodialysis Catherization Set with Arrow Simplicity, Long-Term Access, Cuff to Tip: 31cm, CS-15362-IM, Intended for single use only, Sterile, Rx only. The product is used for long term hemodialysis vascular access RECALL NUMBER # Z-2274-2008 PRODUCT 34) ARROW Edge Hemodialysis Catherization Set, Long-Term Access, Cuff to Tip: 31cm, ASK-15362-I, Intended for single use only, Sterile, Rx only. The product is used for long term hemodialysis vascular access RECALL NUMBER # Z-2275-2008 PRODUCT 35) ARROW Edge Hemodialysis Catherization Set, Long-Term Access, Cuff to Tip: 19cm, CS-15242-I, Intended for single use only, Sterile, Rx only. The product is used for long term hemodialysis vascular access RECALL NUMBER # Z-2276-2008 PRODUCT 36) ARROW Edge Hemodialysis Catherization Set, Long-Term Access, Cuff to Tip: 23cm, CS-15282-I, Intended for single use only, Sterile, Rx only. The product is used for long term hemodialysis vascular access RECALL NUMBER # Z-2277-2008 PRODUCT 37) ARROW Edge Hemodialysis Catherization Set, Long-Term Access, Cuff to Tip: 27cm, CS-15322-I, Intended for single use only, Sterile, Rx only. The product is used for long term hemodialysis vascular access RECALL NUMBER # Z-2278-2008 PRODUCT 38) ARROW Edge Hemodialysis Catherization Set, Long-Term Access, Catheter Length, Cuff to Tip: 31cm, CS-15362-I, Intended for single use only, Sterile, Rx only. The product is used for long term hemodialysis vascular access RECALL NUMBER # Z-2279-2008 PRODUCT 39) ARROW Edge Hemodialysis Catherization Set, Long-Term Access, Catheter Length, Cuff to Tip: 50cm, CS-15552-I, Intended for single use only, Sterile, Rx only. The product is used for long term hemodialysis vascular access RECALL NUMBER # Z-2280-2008 PRODUCT 40) ARROW Edge Hemodialysis Catherization Set, Long-Term Access, Cuff to Tip: 19cm, CSD-15242-I, Intended for single use only, Sterile, Rx only. The product is used for long term hemodialysis vascular access RECALL NUMBER # Z-2281-2008 PRODUCT 41) ARROW Edge Hemodialysis Catherization Set, Long-Term Access, Cuff to Tip: 23cm, CSD-15282-I, Intended for single use only, Sterile, Rx only. The product is used for long term hemodialysis vascular access RECALL NUMBER # Z-2282-2008 PRODUCT 42) ARROW Edge Hemodialysis Catherization Set, Long-Term Access, Cuff to Tip: 27cm, CSD-15322-I, Intended for single use only, Sterile, Rx only. The product is used for long term hemodialysis vascular access RECALL NUMBER # Z-2283-2008 PRODUCT 43) ARROW Edge Hemodialysis Catherization Set, Long-Term Access, Catheter Length, Cuff to Tip: 31cm, CSD-15362-I, Intended for single use only, Sterile, Rx only. The product is used for long term hemodialysis vascular access RECALL NUMBER # Z-2284-2008 PRODUCT 44) ARROW Edge Hemodialysis Catherization Set, Long-Term Access, Catheter Length, Cuff to Tip: 50cm, CSD-15552-I, Intended for single use only, Sterile, Rx only. The product is used for long term hemodialysis vascular access RECALL NUMBER # Z-2285-2008 CODE 1) Lot #RL7065076, RL7054704, RL7034338, RL6123772, RL6113608, RL6103456, and RL6062695 2) Lot#RL7054799, RL7044546, RL044529, RL7034289, RL7024171, RL7013848, RL6123738, RL6113609, RL6083023, RL6072946, and RL6062692 3) Lot#RL7075217, RL7034341, RL7013847, RL6113498, and RL6093309 4) Lot# RL8016430, RL7105756, RL7085366, RL7034449, RL7034288, and RL7013906 5) Lot# RL6093219 6) Lot# RL6022012, RL5111395, RF5061635, and RF5072839 7) Lot# RL5111237, RL5111325, and RF5061636 8) Lot # RL5111238, RL5111377, and RF5072840 9) Lot # RL5121655 10) Lot # RR6032277, RL5111326, and RF5061637 11) Lot # RL7075215, RL7064985, RL7064903, RL7054802, RL7054705, RL7044578, RL7034399, RL7034286, RL7034261, RL7013996, RL7013949, RL7013902, RL6123700, RL6113625, RL6113607, RL6113514, RL6103459, RL6103393, RL6093277, RL6093222, RL6083018, RL6082997, RL6072898, RL6072876, RL6072850, TL6062700, RL6052656, RL6052609, RL6052575, RL6042517, RL6032357, RL6032272, RL6022005, RL6011963, RL6011844, RL6011793, RL5121650, RL5121602, RL5090953, RL5080571, RF5072292, RF5061640, RF5060898, RF65060780, and RF5060301 12) Lot # RL7075150, RL7064986, RL7064906, RL7054803, RL7054788, RL7054736, RL7054683, RL7044663, RL7044624, RL7044585, RL7044550, RL7044523, RL7034284, RL7034260, RL7024169, RL7024104, RL7024055, RL7014000, RL7013948, RL7013904, RL6123775, RL6113626, RL6113515, RL6103458, RL6103395, RL6103338, RL6093225, RL6083143, RL6083140, RL6083094, RL6083071, RL6083016, RL6082995, RL6082973, RL6072909, RL6072864, RL6072851, RL6052657, RL6052642, RL6052610, RL6052576, RL6042518, RL6042442, RL6032353, RL6032273, RL6022085, RL6022007, RL6011823, RL6011738, RL5121604, RL5111324, RL5101066, RL5090954, RL5090813, RR5080673, RF5072293, RF5061641, RF5060901, RF5060302, RF5054487, RF50546780, and RF5055030 13) Lot # RL7116004, RL7065080, RL7054804, RL705735, Lot# RL7054676, Rl7044642, RL7044580, Rl7044502, RL7034343, RL7034263, RL7024056, RL7013999, RL7013950, RL6123778, RL6113627, RL6113599, RL6113492, RL6103457, RL6103394, RL6093276, RL6093220, RL6083122, RL6083020, RL6072902, RL60172877, RL6062701, RL6052658, RL6052611, RL6052604, RL6052577, RL6042447, RL6042443, RL6032355, RL6021983, RL6011962, RL6011956, RL6011794, RL6011735, RL5121426, RL5111374, RL5101070, RL5090955, RL5090812, RF5072294, RF5061642, and RF5060483 14) Lot # RL7054708, RL7044581, RL7034346, RL7034265, RL7024126, RL7013907, RL6123780, RL6113628, RL6103472, RL6083021, RL6082998, RL6072905, RL6072878, RL6062702, RL6052612, RL6042519, RL6032356, RL6022010, RL6011957, RL6011824, RL5121652, RL5111412, RL5101060, RL5090814, RF5084114, and RR5060807 15) Lot # RL7075218, RL7064990, RL7064908, RL7054830, RL7044582, RL7034349, RL7034266, RL7024127, RL6123781, RL6113600, RL6103473, RL6103401, RL6103364, RL6083123, RL6083003, RL6072883, RL6062744, RL6052634, RL6052555, RL6042448, RL6032275, RL6022011, RL6011847, RL6011825, RL6011739, RL5121605, RL5121428, RL5111376, RL5090815, RF5072295, and RF5061643 16) Lot #RL7075165, RL7064971, RL7044662, RL7034337, RL703420, RL7024049, RL7013953, RL6103343, RL6062812, and RL6062755 17) Lot # RL7085440, RL7085404, RL7075211, RL7064954, RL7044506, RL7024090, RL7013829, RL6103375, RL6062769, and RL6062726 18) Lot # RL7095627, RL7095600, RL7085439, RL7075264, RL7075167, RL7065039, RL7034322, RL7024125, RL7013825, RL6103336, RL6062767, and RL6062747 19) Lot # RL7095524, RL7075134, RL7065041, RL7054792, RL7034390, RL7013965, RL6062819, and RL6062756 20) Lot # RL7075168, RL7054790, RL7024123, RL6093201, RL6083117, and RL6062757 21) Lot # RL7065083, RL7064902, RL7054801, RL7024113, RL6103474, RL6093296, RL6083017, RL6082996, RL6062685, RL5101072, and RL5090957 22) Lot # RL7085368, RL7075149, RL7044668, RL7034447, RL7013872, RL6113551, RL6103403, RL6082978, and RL5090961; 23) Lot # RL7034372, RL6093298, RL6083063, RL6072900, and RL5090966 24) Lot # RL7044504, RL7013995, RL6103475, RL6093299, RL6072906, and RL5111239 25) Lot # RL7054829, RL6113552, RL6083022, RL6072884, and RL5101077 26) Lot # RL7075164, RL7064972, RL7044661, RL7034319, RL7013952, RL6123683, RL6113590, RL6103342, RL6103321, RL6082972, RL6062811, RL6052578, RL6032233, RL6022006, RL5111401, RL5111314, RL5111273, RL5090749, RF5071974, and RF5060633 27) Lot # RL7095520, RL7085441, RL7085403, RL7075210, RL7065038, RL7054747, RL7044505, RL7034336, RL7034318, RR7013954, RL7013828, RL6123684, RL6113591, RL6103374, RL6072853, RL6062768, RL6052527, RL6032350, RL6022008, RL6011846, RL6011741, RL5121549, RL5111399, RL5101067, RL5090754, RF5083471, RF5072252, RF5060634, RF5055030, and RF5054823 28) Lot # RL7095626, RL7085438, RL7075166, RL7065040, RL7034321, RL7024124, RL7013824, RL6123697, RL6103335, RL6083070, RL6082980, RL6062766, RL6022021, RL5121547, RL5111400, RL5111259, RF5083830, RF5072253, and RF5060635 29) Lot # RL7095523, RL7075133, RL7054791, RL7034389, RL7013964, RL6123685, RL6083038, RL6082970, RL6062818, RL6032303, RL5121548, RL5111402, RL5111274, RL5090726, RF5083831, and RF5060632 30) Lot # RL7085497, RL7075135, RL7024105, RL7024062, RL7013817, RL6103430, RL6083098, RL6083036, RL6062788, RL6052633, RL6022022, RL6021973, RL5090950, and RR5051996 31) Lot # RL7075140, RL7065024, RL7054781, RL7034393, RL7024052, RL7013831, RL6123782, RL6103334, RL6083092, RL6072882, RL6062813, RL6062783, RL6052613, RL6042444, RL6022023, RL6011960, RL5090951, and RF5054861 32) Lot #RL7075138, RL7065026, RL7034395, RL7024054, RL7013963, RL6113593, RL6062816, RL6062772, RR5101171, RL5101008, and RF5054862 33) Lot# RL7034396, RL6113592, RL6103341, RL6062790, RL5101009, and R5051995 34) Lot #8016512 35) Lot # RL7075136, RL7034391, RL6083099, RL6083037, RL6062789, RL6011934, RL5121649, RL5111321, RR5101165, RF5084348, and RF5072121 36) Lot # RL7075139, RL7065023, RL7054780, RL7034392, RL7024053, RL7013830, RL6123783, RL610333, RL6083093, RL6072881, RL6062814, RL6062784, RR5101166, RL5090831, and RL5090775 37) Lot # RL7075137, RL7065025, RL7054779, RL7034394, RL6113594, RL6083058, RL5121614, RR5101169, RL5090832, RL5090780, and RF505455 38) Lot # RL7013940, RL6062791, RR5101168, RL5090833, and RL5090776 39) Lot # RL7034397, RL7013939, RL6062815, RL6062792, RL5121654, RL5090834, RL5080628, and RF5060906 40) Lot# RL7065082, RL6093295, and RL6082990 41) Lot # RL7075214, RL6103402, and RL6083025 42) Lot # RL6123742, RL6083061, and RL6082992 43) Lot # RL7064991, RL6083027 44) Lot # RL7065084, and RL6093204 MANUFACTURER Arrow International Inc., Asheboro, NC RECALLED BY Arrow International Inc., Reading, PA QUANTITY 79,248 units DISTRIBUTION Nationwide and Internationally REASON The tips may not have been adequately welded to the catheter body. ---------------------------------------------------------------------------