NRAC Issue #1669 ADDENDUM February 12, 2008 THE FOLLOWING IS AN UPDATE TO A CLASS I RECALL THAT APPEARED IN NRAC ISSUE #1667 DATED 1/29/08 THE FOLLOWING IS A CLASS I RECALL. THERE IS A REASONABLE PROBABILITY THAT THE USE OF THE AFFECTED PRODUCT MAY CAUSE SERIOUS INJURY OR DEATH IF THE PROBLEM IS NOT CORRECTED. PRODUCT 1) CORDIS "Dura Star" 2.25 x 10 Dilatation Catheter, Catalog # 70110225 RECALL NUMBER # Z-0747-2008 PRODUCT 2) CORDIS "Dura Star" 2.50 x 10 Dilatation Catheter, Catalog # 70110250 RECALL NUMBER # Z-0748-2008 PRODUCT 3) CORDIS "Dura Star" 2.75 x 10 Dilatation Catheter, Catalog # 70110275 RECALL NUMBER # Z-0749-2008 PRODUCT 4) CORDIS "Dura Star" 3.00 x 10 Dilatation Catheter, Catalog # 70110300 RECALL NUMBER # Z-0750-2008 PRODUCT 5) CORDIS "Dura Star" 3.25 x 10 Dilatation Catheter, Catalog # 70110325 RECALL NUMBER # Z-0751-2008 PRODUCT 6) CORDIS "Dura Star" 3.50 x 10 Dilatation Catheter, Catalog # 70110350 RECALL NUMBER # Z-0752-2008 PRODUCT 7) CORDIS "Dura Star" 3.75 x 10 Dilatation Catheter, Catalog # 70110375 RECALL NUMBER # Z-0753-2008 PRODUCT 8) CORDIS "Dura Star" 4.00 x 10 Dilatation Catheter, Catalog # 70110400 RECALL NUMBER # Z-0754-2008 PRODUCT 9) CORDIS "Dura Star" 2.25 x 15 Dilatation Catheter, Catalog # 70115225 RECALL NUMBER # Z-0755-2008 PRODUCT 10) CORDIS "Dura Star" 2.50 x 15 Dilatation Catheter, Catalog # 70115250 RECALL NUMBER # Z-0756-2008 PRODUCT 11) CORDIS "Dura Star" 2.75 x 15 Dilatation Catheter, Catalog # 70115275 RECALL NUMBER # Z-0757-2008 PRODUCT 12) CORDIS "Dura Star" 3.00 x 15 Dilatation Catheter, Catalog # 70115300 RECALL NUMBER # Z-0758-2008 PRODUCT 13) CORDIS "Dura Star" 3.25 x 15 Dilatation Catheter, Catalog # 70115325 RECALL NUMBER # Z-0759-2008 PRODUCT 14) CORDIS "Dura Star" 3.50 x 15 Dilatation Catheter, Catalog # 70115350 RECALL NUMBER # Z-0760-2008 PRODUCT 15) CORDIS "Dura Star" 3.75 x 15 Dilatation Catheter, Catalog # 70115375 RECALL NUMBER # Z-0761-2008 PRODUCT 16) CORDIS "Dura Star" 4.00 x 15 Dilatation Catheter, Catalog # 70115400 RECALL NUMBER # Z-0762-2008 PRODUCT 17) CORDIS "Dura Star" 2.25 x 20 Dilatation Catheter, Catalog # 70120225 RECALL NUMBER # Z-0763-2008 PRODUCT 18) CORDIS "Dura Star" 2.50 x 20 Dilatation Catheter, Catalog # 70120250 RECALL NUMBER # Z-0764-2008 PRODUCT 19) CORDIS "Dura Star" 2.75 x 20 Dilatation Catheter, Catalog # 70120275 RECALL NUMBER # Z-0765-2008 PRODUCT 20) CORDIS "Dura Star" 3.00 x 20 Dilatation Catheter, Catalog # 70120300 RECALL NUMBER # Z-0766-2008 PRODUCT 21) CORDIS "Dura Star" 3.25 x 20 Dilatation Catheter, Catalog # 70120325 RECALL NUMBER # Z-0767-2008 PRODUCT 22) CORDIS "Dura Star" 3.50 x 20 Dilatation Catheter, Catalog # 70120350 RECALL NUMBER # Z-0768-2008 PRODUCT 23) CORDIS "Dura Star" 3.75 x 20 Dilatation Catheter, Catalog # 70120375 RECALL NUMBER # Z-0769-2008 PRODUCT 24) CORDIS "Dura Star" 4.00 x 20 Dilatation Catheter, Catalog # 70120400 RECALL NUMBER # Z-0770-2008 PRODUCT 25) CORDIS "Dura Star" 2.25 x 25 Dilatation Catheter, Catalog # 70125225 RECALL NUMBER # Z-0771-2008 PRODUCT 26) CORDIS "Dura Star" 2.50 x 25 Dilatation Catheter, Catalog # 70125250 RECALL NUMBER # Z-0772-2008 PRODUCT 27) CORDIS "Dura Star" 2.75 x 25 Dilatation Catheter, Catalog # 70125275 RECALL NUMBER # Z-0773-2008 PRODUCT 28) CORDIS "Dura Star" 3.00 x 25 Dilatation Catheter, Catalog # 70125300 RECALL NUMBER # Z-0774-2008 PRODUCT 29) CORDIS "Dura Star" 3.25 x 25 Dilatation Catheter, Catalog # 70125325 RECALL NUMBER # Z-0775-2008 PRODUCT 30) CORDIS "Dura Star" 3.50 x 25 Dilatation Catheter, Catalog # 70125350 RECALL NUMBER # Z-0776-2008 PRODUCT 31) CORDIS "Dura Star" 3.75 x 25 Dilatation Catheter, Catalog # 70125375 RECALL NUMBER # Z-0777-2008 PRODUCT 32) CORDIS "Dura Star" 4.00 x 25 Dilatation Catheter, Catalog # 70125400 RECALL NUMBER # Z-0778-2008 PRODUCT 33) CORDIS "Dura Star" 2.25 x 30 Dilatation Catheter, Catalog # 70130225 RECALL NUMBER # Z-0779-2008 PRODUCT 34) CORDIS "Dura Star" 2.50 x 30 Dilatation Catheter, Catalog # 70130250 RECALL NUMBER # Z-0780-2008 PRODUCT 35) CORDIS "Dura Star" 2.75 x 30 Dilatation Catheter, Catalog # 70130275 RECALL NUMBER # Z-0781-2008 PRODUCT 36) CORDIS "Dura Star" 3.00 x 30 Dilatation Catheter, Catalog # 70130300 RECALL NUMBER # Z-0782-2008 PRODUCT 37) CORDIS "Dura Star" 3.25 x 30 Dilatation Catheter, Catalog # 70130325 RECALL NUMBER # Z-0783-2008 PRODUCT 38) CORDIS "Dura Star" 3.50 x 30 Dilatation Catheter, Catalog # 70130350 RECALL NUMBER # Z-0784-2008 PRODUCT 39) CORDIS "Dura Star" 3.75 x 30 Dilatation Catheter, Catalog # 70130375 RECALL NUMBER # Z-0785-2008 PRODUCT 40) CORDIS "Dura Star" 4.00 x 30 Dilatation Catheter, Catalog # 70130400 RECALL NUMBER # Z-0786-2008 PRODUCT 41) CORDIS "Fire Star" 1.50 x 10, Dual Maker Band, Dilatation Catheter, Catalog # 8011015D RECALL NUMBER # Z-0787-2008 PRODUCT 42) CORDIS "Fire Star" 1.50 x 10, Single Marker Band, Dilatation Catheter, Catalog # 8011015S RECALL NUMBER # Z-0788-2008 PRODUCT 43) CORDIS "Fire Star" 2.00 x 10, Dual Marker Band, Dilatation Catheter, Catalog # 8011020D RECALL NUMBER # Z-0789-2008 PRODUCT 44) CORDIS "Fire Star" 2.00 x 10, Single Marker Band, Dilatation Catheter, Catalog # 8011020S RECALL NUMBER # Z-0790-2008 PRODUCT 45) CORDIS "Fire Star" 2.25 x 10 Dilatation Catheter, Catalog # 80110225 RECALL NUMBER # Z-0791-2008 PRODUCT 46) CORDIS "Fire Star" 2.50 x 10 Dilatation Catheter, Catalog # 80110250 RECALL NUMBER # Z-0792-2008 PRODUCT 47) CORDIS "Fire Star" 2.75 x 10 Dilatation Catheter, Catalog # 80110275 RECALL NUMBER # Z-0793-2008 PRODUCT 48) CORDIS "Fire Star" 3.00 x 10 Dilatation Catheter, Catalog # 80110300 RECALL NUMBER # Z-0794-2008 PRODUCT 49) CORDIS "Fire Star" 3.25 x 10 Dilatation Catheter, Catalog # 80110325 RECALL NUMBER # Z-0795-2008 PRODUCT 50) CORDIS "Fire Star" 3.50 x 10 Dilatation Catheter, Catalog # 80110350 RECALL NUMBER # Z-0796-2008 PRODUCT 51) CORDIS "Fire Star" 1.50 x 15, Dual Marker Band, Dilatation Catheter, Catalog # 8011515D RECALL NUMBER # Z-0797-2008 PRODUCT 52) CORDIS "Fire Star" 1.50 x 15, Single Marker Band, Dilatation Catheter, Catalog # 8011515S RECALL NUMBER # Z-0798-2008 PRODUCT 53) CORDIS "Fire Star" 2.00 x 15, Dual Marker Band, Dilatation Catheter, Catalog # 8011520D RECALL NUMBER # Z-0799-2008 PRODUCT 54) CORDIS "Fire Star" 2.00 x 15, Single Marker Band, Dilatation Catheter, Catalog # 8011520S RECALL NUMBER # Z-0800-2008 PRODUCT 55) CORDIS "Fire Star" 2.25 x 15 Dilatation Catheter, Catalog # 80115225 RECALL NUMBER # Z-0801-2008 PRODUCT 56) CORDIS "Fire Star" 2.50 x 15 Dilatation Catheter, Catalog # 80115250 RECALL NUMBER # Z-0802-2008 PRODUCT 57) CORDIS "Fire Star" 2.75 x 15 Dilatation Catheter, Catalog # 80115275 RECALL NUMBER # Z-0803-2008 PRODUCT 58) CORDIS "Fire Star" 3.00 x 15 Dilatation Catheter, Catalog # 80115300 RECALL NUMBER # Z-0804-2008 PRODUCT 59) CORDIS "Fire Star" 3.25 x 15 Dilatation Catheter, Catalog # 80115325 RECALL NUMBER # Z-0805-2008 PRODUCT 60) CORDIS "Fire Star" 3.50 x 15 Dilatation Catheter, Catalog # 80115350 RECALL NUMBER # Z-0806-2008 PRODUCT 61) CORDIS "Fire Star" 1.50 x 20, Dual Marker Band , Dilatation Catheter, Catalog # 8012015D RECALL NUMBER # Z-0807-2008 PRODUCT 62) CORDIS "Fire Star" 1.50 x 20, Single Marker Band, Dilatation Catheter, Catalog # 8012015S RECALL NUMBER # Z-0808-2008 PRODUCT 63) CORDIS "Fire Star" 2.00 x 20, Dual Marker Band, Dilatation Catheter, Catalog # 8012020D RECALL NUMBER # Z-0809-2008 PRODUCT 64) CORDIS "Fire Star" 2.00 x 20, Single Marker Band, Dilatation Catheter, Catalog # 8012020S RECALL NUMBER # Z-0810-2008 PRODUCT 65) CORDIS "Fire Star" 2.25 x 20 Dilatation Catheter, Catalog # 80120225 RECALL NUMBER # Z-0811-2008 PRODUCT 66) CORDIS "Fire Star" 2.50 x 20 Dilatation Catheter, Catalog # 80120250 RECALL NUMBER # Z-0812-2008 PRODUCT 67) CORDIS "Fire Star" 2.75 x 20 Dilatation Catheter, Catalog # 80120275 RECALL NUMBER # Z-0813-2008 PRODUCT 68) CORDIS "Fire Star" 3.00 x 20 Dilatation Catheter, Catalog # 80120300 RECALL NUMBER # Z-0814-2008 PRODUCT 69) CORDIS "Fire Star" 3.25 x 20 Dilatation Catheter, Catalog # 80120325 RECALL NUMBER # Z-0815-2008 PRODUCT 70) CORDIS "Fire Star" 3.50 x 20 Dilatation Catheter, Catalog # 80120350 RECALL NUMBER # Z-0816-2008 PRODUCT 71) CORDIS "Fire Star" 2.00 x 30, Dual Marker Band, Dilatation Catheter, Catalog # 8013020D RECALL NUMBER # Z-0817-2008 PRODUCT 72) CORDIS "Fire Star" 2.00 x 30, Single Marker Band, Dilatation Catheter, Catalog # 8013020S RECALL NUMBER # Z-0818-2008 PRODUCT 73) CORDIS "Fire Star" 2.25 x 30 Dilatation Catheter, Catalog # 80130225 RECALL NUMBER # Z-0819-2008 PRODUCT 74) CORDIS "Fire Star" 2.50 x 30 Dilatation Catheter, Catalog # 80130250 RECALL NUMBER # Z-0820-2008 PRODUCT 75) CORDIS "Fire Star" 2.75 x 30 Dilatation Catheter, Catalog # 80130275 RECALL NUMBER # Z-0821-2008 PRODUCT 76) CORDIS "Fire Star" 3.00 x 30 Dilatation Catheter, Catalog # 80130300 RECALL NUMBER # Z-0822-2008 PRODUCT 77) CORDIS "Fire Star" 3.25 x 30 Dilatation Catheter, Catalog # 80130325 RECALL NUMBER # Z-0823-2008 PRODUCT 78) CORDIS "Fire Star" 3.50 x 30 Dilatation Catheter, Catalog # 80130350 RECALL NUMBER # Z-0824-2008 CODE ÿ1) Lot #s: 13193169 13231743 13237267 13266367 13269602 13271042 13272422 ÿÿÿÿ 13299493 13303055 and 13314184; ÿ2) Lot #s: 13175336 13180557 13189422 13190774 13208064 13209913 13209921 ÿÿÿÿ 13211074 13217606 13225515 13245564 13250081 13251126 13252416 13266368 ÿÿÿÿ 13269603 13272936 13278669 13285514 13289737 13297291 13298192 13300591 ÿÿÿÿ 13303777 13305476 13309104 and 13314185; ÿ3) Lot #s: 13193167 13208065 13212428 13222114 13249530 13250702 13250954 ÿÿÿÿ 13266369 13269604 13271043 13272423 13298187 13298780 13305478 and ÿÿÿÿ 13309106, ÿ4) Lot #s: 13175335 13180558 13182673 13189425 13198875 13207206 13208066 ÿÿÿÿ 13209922 13211075 13217618 13237269 13245566 13251127 13255234 13266370 ÿÿÿÿ 13269605 13271045 13272424 13275164 13281459 13281460 13281461 13282478 ÿÿÿÿ 13287294 13289742 13291882 13298188 13298781 13302297 13312712 13312716 ÿÿÿÿ and 13313278; ÿ5) Lot #s: 13193166 13207018 13207207 13208067 13212430 13222116 13237701 ÿÿÿÿ 13267861 13271047 13272937 13272938 13282048 13285515 13292687 13298782 ÿÿÿÿ 13309107 and 13314186; ÿ6) Lot #s: 13175334 13180559 13183022 13189427 13190063 13207208 13208068 ÿÿÿÿ 13209914 13237270 13245567 13256453 13258616 13260158 13262741 13267862 ÿÿÿÿ 13271048 13272941 13272942 13275165 13278670 13279267 13288829 13292688 ÿÿÿÿ 13297292 13301346 13303778 13305481 13310832 13314810 and 13315454; ÿ7) Lot #s: 13185378 13189428 13229382 13271050 13275926 13275929 13278671 ÿÿÿÿ 13288835 13288864 13302298 13305482 and 13310110; ÿ8) Lot #s: 13185384 13201699 13202614 13209924 13217621 13237702 13267864 ÿÿÿÿ 13271053 13275166 13275931 13289745 13298784 13299489 13300592 13303779 ÿÿÿÿ 13305484 and 13310111; ÿ9) Lot #s: 13193170 13207020 13209761 13231745 13250078 13251128 13255235 ÿÿÿÿ 13267865 13271054 13275167 13275933 13292689 13298785 13305486 and ÿÿÿÿ 13314811; 10) Lot #s: 13175337 13180560 13183023 13195487 13195988 13207209 13209762 ÿÿÿÿÿ 13209915 13209925 13211070 13216629 13217623 13222115 13250079 13250082 ÿÿÿÿÿ 13255236 13255238 13271057 13275168 13277834 13278672 13285156 13290329 ÿÿÿÿÿ 13291123 13298189 13298786 13300595 13303780 13305487 13310112 and ÿÿÿÿÿ 13314812; 11) Lot #s: 13185357 13195488 13195989 13209916 13216630 13245568 13267867 ÿÿÿÿÿ 13274854 13275169 13279924 13285517 13291124 13291889 13310113 and ÿÿÿÿÿ 13313279; 12) Lot #s: 13173912 13182671 13185355 13189430 13190065 13207021 13207210 ÿÿÿÿÿ 13208754 13209926 13211071 13217625 13266340 13267868 13270374 13271060 ÿÿÿÿÿ 13274855 13275193 13277836 13278673 13279268 13279925 13279926 13286195 ÿÿÿÿÿ 13286196 13291890 13297294 13298787 13300601 13300606 13302299 13306282 ÿÿÿÿÿ 13310114 13310115 13313280 13314813 and 13315455; 13) Lot #s: 13185358, 13195489, 13208755, 13211072, 13216626, 13222117, 13250080, 13269606, 13271113, 13276827, 13276828, 13301347, 13306289, 13310833, and 13314814; 14) Lot #: 13173913, 13183024, 13187317, 13189432, 13207022, 13207211, 13208756, ÿÿÿÿÿ 13209927, 13217627, 13251129, 13255239, 13256459, 13269607, 13271115, ÿÿÿÿÿ 13279269, 13279271, 13279928, 13288050, 13291891, 13299496, 13301348, ÿÿÿÿÿ 13303765, 13306290, and 13310834; 15) Lot #: 13188120, 13196602, 13229383, 13251130, 13269608, 13271122, ÿÿÿÿÿ 13276831, 13288828, 13288836, 13302230, and 13306291; 16) Lot #: 13183025, 13190066, 13195990, 13202619, 13212432, 13225518, ÿÿÿÿÿ 13245569, 13250083, 13255240, 13271520, 13276832, 13298190, 13299498, ÿÿÿÿÿ 13300608, 13301351, 13306292, 13310835 and 13313277; 17) Lot #s: 13185389 13207023 13242125 13244437 13250084 13252058 ÿÿÿÿÿ 13271522 13276833 13290331 and 13306293; 18) Lot #s 13173915 13183026 13184579 13190067 13207024 13208757 13222118 ÿÿÿÿÿ 13242126 13258617 13264541 13271523 13277608 13281462 13281463 ÿÿÿÿÿ 13283203 13283821 13289728 13310836 and 13313281; 19) Lot #s 13193171 13200884 13237703 13260159 13271525 13277609 13277610 ÿÿÿÿÿ 13285518 13290332 13301353 and 13310837; 20) Lot #s 13173916 13180564 13183027 13190137 13195490 13195991 13196603 ÿÿÿÿÿ 13208758 13209918 13217586 13251131 13264542 13271526 13279927 ÿÿÿÿÿ 13280398 13282479 13283204 13298191 13299499 13303069 13306830 ÿÿÿÿÿ 13307820 13308634 13311780 13312718 and 13319349; 21) Lot #s 13185363 13200885 13242127 13260160 13262742 13272429 13283205 ÿÿÿÿÿ 13302231 and 13303061; 22) Lot #s 13173918 13180565 13183028 13195992 13200886 13211073 13260774 ÿÿÿÿÿ 13264256 13266341 13267183 13270375 13272420 13273243 13280399 ÿÿÿÿÿ 13280400 13282481 13284565 13302232 13303064 13306831 and 13313282; 23) Lot #s 13185390 13196604 13201701 13250703 13273244 13273245 13287293 ÿÿÿÿÿ 13306832 13311781 and 13312719; 24) Lot #s 13190139 13195993 13201702 13207025 13209928 13217629 13288049 ÿÿÿÿÿ 13308636 13311782 and 13312720; 25) Lot #s: 13237709 13260775 and 13277616; 26) Lot #s: 13194477 13240537 13260776 13277618 and 13283206; 27) Lot #s 13222120 13237710 13259550 13264543 13272426 13311783 and ÿÿÿÿÿ 13312721; 28) Lot #s: 13194474 13207026 13239268 13260777 13264257 13282482 13283822 ÿÿÿÿÿ and 13288838; 29) Lot #s: 13229384 13258618 13266342 13270376 and 13288052; 30) Lot #s: 13194475 13207027 13267184 13272421 13274540 13283208 and ÿÿÿÿÿ 13292695; 31) Lot #s: 13201703 13273246 and 13288051; 32) Lot #s: 13222119 13237711 13273247 and 13292696; 33) Lot #s: 13264544 13273248 and 13285519; 34) Lot #s: 13194476 13209920 13216633 13264545 13283823 and 13291892; 35) Lot #s: 13220453 13258619 13273930 and 13313276; 36) Lot #s: 13194478 13208759 13220454 13237704 13273935 13287295 and ÿÿÿÿÿ 13299502; 37) Lot #s: 13231748 13251132 13259551 13273938 and 13299503; 38) Lot #s: 13194472 13220455 13242128 13277621 13284566 and 13290333; 39) Lot #s: 13237714 13244439 13252060 13273940 and 13288053; 40) Lot #s: 13208760 13273941 and 13287296; 41) Lot #s: 13200863 13221408 13224938 13235880 13264547 13271983 13280404 ÿÿÿÿÿ 13281196 13281257 13281376 13281426 13288054 13291130 13305475 ÿÿÿÿÿ 13307824 13311784 13316297 and 13321689; 42) Lot #s: 13200864 13214547 13222777 13224939 13267185 13271984 13278328 ÿÿÿÿÿ 13281203 13281252 13281343 13289747 13293669 13307825 13307826 and ÿÿÿÿÿ 13316296; 43) Lot #s: 13188605 13192861 13195491 13205387 13212421 13214548 13222778 ÿÿÿÿÿ 13224932 13227002 13230714 13232858 13237698 13237904 13245573 ÿÿÿÿÿ 13258620 13260780 13267186 13281342 13281424 13282061 13290334 ÿÿÿÿÿ 13291893 13293578 13293670 13295101 13304555 13305488 13309108 ÿÿÿÿÿ 13313284 13319350 and 13321696; 44) Lot #s: 13221409 13232859 13239271 13253242 13258623 13274856 13290335 ÿÿÿÿÿ 13293671 and 13295102; 45) Lot #s: 13188606 13206122 13218314 13223382 13235878 13240535 13246853 ÿÿÿÿÿ 13253243 13260781 13276280 13290336 13293672 13296511 and 13296512; 46) Lot #s: 13191352 13191802 13199593 13203919 13214549 13215774 13222780 ÿÿÿÿÿ 13230715 13237699 13239273 13263486 13267187 13281191 13281255 ÿÿÿÿÿ 13281337 13281339 13281340 13281346 13281370 13281430 13291894 ÿÿÿÿÿ 13292697 13293579 13295103 13298195 13304556 13305489 13305490 ÿÿÿÿÿ 13309109 13313285 13314815 and 13319351; 47) Lot #s: 13206124 13211696 13218315 13245576 13253840 13253841 13253842 ÿÿÿÿÿ 13260782 13281192 13296513 13305491 and 13319352; 48) Lot #s: 13187443 13191353 13191803 13197618 13205388 13214550 13224936 ÿÿÿÿÿ 13227004 13237905 13260784 13264548 13265028 13268849 13281188 ÿÿÿÿÿ 13281275 13281292 13281403 13281433 13289749 13293580 13293673 ÿÿÿÿÿ 13295104 13301356 13305496 13309110 13314816 and 13323195; 49) Lot #s: 13237906 13241421 13248671 13262225 13265031 13287297 13299506 ÿÿÿÿÿ 13301358 13305497 and 13319353; 50) Lot #s: 13211699 13228631 13239274 13255242 13278332 13279594 13281187 ÿÿÿÿÿ 13281293 13281407 13282049 13293674 13294164 13294165 13301364 ÿÿÿÿÿ 13303083 13305499 13319354 and 13321701; 51) Lot #s: 13205389 13223380 13230717 13237907 13241423 13247913 13252063 ÿÿÿÿÿ 13255241 13265032 13281283 13281412 13282062 13283829 13284568 ÿÿÿÿÿ 13288831 13291131 13294197 13294202 13305500 13310116 and 13319355; ÿ52) Lot #s: 13205390 13206126 13214552 13215775 13237700 13239276 13252064 ÿÿÿÿÿÿ 13278334 13281222 13281272 13281303 13281394 13281434 13292698 ÿÿÿÿÿÿ 13293675 13294203 13294204 13294205 13294206 13301365 13303084 and ÿÿÿÿÿÿ 13323515; 53) Lot #s: 13187444 13191354 13191804 13191806 13197619 13199595 13211692 ÿÿÿÿÿ 13214551 13218320 13221410 13221411 13224181 13224183 13227940 ÿÿÿÿÿ 13229366 13230718 13237908 13242132 13244057 13246357 13247914 ÿÿÿÿÿ 13251133 13255710 13262746 13268852 13281396 13281411 13282063 ÿÿÿÿÿ 13283824 13283830 13283831 13284569 13285521 13288833 13289751 ÿÿÿÿÿ 13291895 13295105 13297306 13301370 13304557 13309111 13313286 ÿÿÿÿÿ 13316796 13321809 and 13323516; 54) Lot #s: 13222781 13224941 13232861 13248678 13258624 13262747 13265034ÿÿÿ ÿÿÿÿÿ 13281409 13293676 13296514 13320188 and 13329054; 55) Lot #s: 13203920 13214554 13216623 13222783 13224942 13242133 13255711 ÿÿÿÿÿ 13264400 13268856 13281194 13281400 13281448 13296515 13306294 ÿÿÿÿÿ 13310117 13320189 13324439 and 13329055; 56) Lot #s: 13187445 13191016 13191800 13197620 13197621 13200143 13200144 ÿÿÿÿÿ 13200145 13218321 13221412 13221413 13222784 13224943 13224944 ÿÿÿÿÿ 13230719 13235886 13237909 13246358 13247915 13252066 13253834 ÿÿÿÿÿ 13265037 13268858 13279599 13281193 13281201 13281202 13281224 ÿÿÿÿÿ 13281267 13281302 13281318 13281390 13281431 13281450 13282064 ÿÿÿÿÿ 13283832 13284570 13285522 13288834 13289754 13292702 13293582 ÿÿÿÿÿ 13293583 13295106 13298196 13304558 13306300 13307100 13310118 ÿÿÿÿÿ 13310119 13313287 13313288 13318531 13320190 13321811 and 13324440; 57) Lot #s: 13203921 13222786 13242135 13246856 13261564 13276281 13279602 ÿÿÿÿÿ 13281189 13281309 13291128 13293677 13302300 13314817 and 13325098; 58) Lot #s: 13187446 13191355 13197622 13200865 13214556 13221415 13223385 ÿÿÿÿÿ 13225878 13231289 13236340 13239277 13247916 13261565 13264549 ÿÿÿÿÿ 13268859 13279605 13280401 13280405 13281186 13281219 13281279 ÿÿÿÿÿ 13281314 13281364 13281432 13281451 13282065 13284571 13287298 ÿÿÿÿÿ 13292703 13293584 13295107 13304559 13306306 13309113 13314818 ÿÿÿÿÿ 13315461 13317743 and 13321813; 59) Lot #s: 13242130 13246858 13252070 13254534 13259345 13279611 13281312 ÿÿÿÿÿ 13281452 13288056 13302301 and 13320192; 60) Lot #s: 13211700 13216622 13251135 13271985 13274542 13281195 13281226 ÿÿÿÿÿ 13281311 13281368 13281438 13282050 13284572 13287300 13287302 ÿÿÿÿÿ 13291129 13306317 13307101 and 13321815; 61) Lot #s: 13216621 13216625 13223377 13223379 13264551 13268860 13278339 ÿÿÿÿÿ 13281190 13281227 13281375 13281405 13281454 13283209 13284573 ÿÿÿÿÿ 13288057 13293585 13295108 13304560 13306318 and 13320193; 62) Lot #s: 13205391 13214555 13225514 13231292 13232325 13236341 13239278 ÿÿÿÿÿ 13281236 13281280 13281371 13281422 13281443 13281455 13286586 ÿÿÿÿÿ 13294207 13294209 13294210 13306833 13307827 and 13325803; 63) Lot #s: 13187447 13191356 13197623 13197624 13200866 13200867 13206136 ÿÿÿÿÿ 13206138 13212422 13212423 13218318 13223383 13225879 13225880 13225881 ÿÿÿÿÿ 13227558 13233514 13236342 13237910 13244058 13244489 13246359 13246860 ÿÿÿÿÿ 13247917 13251136 13252924 13254620 13281299 13281397 13281453 13282066 ÿÿÿÿÿ 13282067 13284574 13288058 13289756 13296516 13296517 13318532 13321817 ÿÿÿÿÿ and 13325804; 64) Lot #s: 13215777 13228634 13244490 13254622 13259346 13264097 13281315 ÿÿÿÿÿ 13281395 13286585 13289757 13297296 and 13325805; 65) Lot #s: 13211694 13221103 13233515 13243868 13249524 13254624 13261566 ÿÿÿÿÿ 13264098 13276282 13279281 13280402 13281428 13286584 13289759 ÿÿÿÿÿ 13294553 13298193 13321819 and 13325806; 66) Lot #s: 13187448 13191357 13197625 13197626 13203922 13203923 13212424 ÿÿÿÿÿ 13212425 13224187 13224189 13225882 13231288 13232326 13233516 13236343 ÿÿÿÿÿ 13237912 13242129 13246360 13247918 13252929 13253835 13270369 13279283 ÿÿÿÿÿ 13280403 13281233 13281287 13281301 13281328 13281330 13281333 13281392 ÿÿÿÿÿ 13281399 13281427 13282483 13283210 13285523 13288830 13290337 13292699 ÿÿÿÿÿ 13294554 13297302 13302302 13306834 13311785 13313289 13314187 13315462 ÿÿÿÿÿ 13316298 13317745 13321822 13325807 13325808; 67) Lot #s: 13203924 13236344 13243871 13247475 13249525 13262223 13276283ÿ ÿÿÿÿÿ 13281423 13282484 13283211 13285524 13294556 13298194 13306835 ÿÿÿÿÿ 13311787 and 13320194; 68) Lot #s: 13187449 13191017 13197627 13200868 13212426 13212427 13218323 ÿÿÿÿÿ 13224191 13226740 13230694 13231290 13233901 13239280 13246361 ÿÿÿÿÿ 13247919 13252930 13281217 13281229 13281239 13281288 13281300 ÿÿÿÿÿ 13281345 13281429 13281441 13281458 13282485 13283825 13286193 ÿÿÿÿÿ 13290338 13294211 13294557 13294558 13301371 13303085 13304561 ÿÿÿÿÿ 13311788 13311789 13311798 13312722 13314188 13321832 and 13325101; 69) Lot #s: 13239281 13244441 13249526 13259347 13264101 13270371 13276286 ÿÿÿÿÿ 13283212 13292700 13294559 13298788 13303086 13312723 and 13320195; 70) Lot #s: 13221105 13221107 13274544 13281200 13281237 13281285 13281306 ÿÿÿÿÿ 13281425 13281449 13282486 13283213 13286194 13287301 13303767 13307102 ÿÿÿÿÿ 13308631 13312724 13320196 and 13325102; 71) Lot #s: 13206013 13214559 13223384 13224192 13244440 13244444 13264103 ÿÿÿÿÿ 13270373 13278344 13281297 13283826 13292701 13298789 and 13303768; 72) Lot #s: 13229370 13233904 13244445 13255701 13259349 13264104 13278341 ÿÿÿÿÿ 13283827 13298790 and 13312725; 73) Lot #s: 13229371 13244447 13264105 13276289 13299504 13307370 13307743 ÿÿÿÿÿÿ and 13313283; 74) Lot #s: 13205394 13218324 13229373 13231293 13236345 13252940 13278346 ÿÿÿÿÿ 13281234 13281298 13283828 13294215 13294217 13294219 13294220 ÿÿÿÿÿ 13294222 13294561 13299505 and 13308203; 75) Lot #s: 13220450 13239283 and 13281313; 76) Lot #s: 13206014 13214558 13218325 13223381 13239284 13281261 13281440 ÿÿÿÿÿ 13281442 13294224 13294227 13294232 13303772 13308632 and 13312726; 77) Lot #s: 13235546 13246362 13262743 13276291 13288055 and 13303774; 78) Lot #s: 13220452 13246363 13281286 13281336 and 13288059 MANUFACTURED & RECALLED BY Cordis Corporation, Miami Lakes, FL QUANTITY 133,300 units DISTRIBUTION Nationwide and Internationally REASON Slow deflation or no deflation. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT White-Faced Hornet Venom Protein, Allergenic Extract Hymenoptera Venom Product, Multidose 13.0 mL (1300 mcg per vial, 12 dose), freeze dried. Sterile Albumin Saline with Phenol (0.4%) RECALL NUMBER # B-0796-08 CODE Lot No. 1332101C Final Exp: 06/18/2010 MANUFACTURED & RECALLED BY Hollister Stier Laboratories LLC, Spokane, WA QUANTITY 90 vials DISTRIBUTION Nationwide REASON Allergenic Extracts, with a potential for sterility to be compromised, were distributed. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ THE FOLLOWING IS AN UPDATE TO A RECALL THAT APPEARED IN NRAC ISSUE #1661 DATED 12/18/07 PRODUCT a) Pedvax HIB. Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate. The product is shipped 10 single dose vials per carton. NDC # 0006-4897-00 RECALL NUMBER # B-0731-08 PRODUCT b) COMVAX. Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant Vaccine). The product is shipped 10 single dose vials per carton. NDC # 0006-4898-00 RECALL NUMBER # B-0732-08 CODE a) Domestic Lot numbers 0677U exp 1/11/2010, 0820U exp 1/12/2010, 0995U exp 1/16/2010, 1164U exp 1/18/2010, 0259U exp 10/17/2009, 0435U exp 10/18/2009, 0436U exp 10/19/2009, 0437U exp 10/19/2009, 0819U exp 1/9/2010, and 1167U exp 1/10/2010. Lot number shipped to China J2438 exp 10/24/2009. CDC Lot numbers 1690U exp 3/21/2010, 1685U exp 2/22/2010, 1686U exp 2/25/2010, 1687U exp 3/15/2010, 1688U exp 3/16/2010, and 1689U exp 3/19/2010; b) Domestic Lot numbers 0376U exp 1/5/2010 and 0377U exp 1/8/2010. CDC Lot numbers 1727U exp 4/12/2010, 1668U exp 3/13/2010, and 0658323 exp 4/10/2010 MANUFACTURED & RECALLED BY Merck & Co., Inc., West Point, PA QUANTITY 1,129,180 doses + 890,938 CDC DISTRIBUTION Nationwide and China REASON Vaccines, with a lack of sterility assurance, were distributed. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT COBE Spectra Disposable Tubing Set, Dual-Needle Extended Life Platelet Set with LRS Chamber, Catalog Numbers: 777110, 70300, 70310, and 777003015. COBE Spectra Disposable Tubing Set, Single-Needle Extended Life Platelet Set with LRS Chamber, Catalog Number 70400 and 777003215. COBE Spectra Disposable Tubing Set, Dual-Needle Extended Life Platelet Set, Catalog Number 70100 and 777003005. Trima LRS Platelet, Plasma, RBC Set with Sharps Protection, Catalog number 777800100. Trima Accel LRS Platelet, Plasma, RBC Set, Catalog Number 777800400; 777800401; Catalog Number 777800403. Trima Accel LRS Platelet, Plasma, RBC + TLR Filter Set, Catalog number 777800450 and 777800451 and 777800453. Trima Accel LRS Platelet, Plasma Set, Catalog number 80300. Trima Accel LRS Platelet, Plasma, RBC Set, Catalog Number 80400. Trima Accel LRS Platelet, Plasma, RBC + Auto P.A.S. Set, Catalog number 80410, 80411, 80413. Trima Accel Enhanced Platelet, Plasma, RBC + Auto P.A.S. Set, Catalog number 80420. Trima Accel Enhanced Platelet, Plasma, RBC Set, Catalog number 80440 and 80449. Trima Accel LRS Platelet, Plasma RBC + TLR Filter Set, Catalog number 80450. Trima Accel PPC, Plasma, RBC + TLR Filter Set, Catalog number 80460. Trima Accel LRS Platelet, Plasma, RBC + TLR Filter + Auto P.A.S. Set, Catalog number 80480 and 80483. Trima Accel Enhanced PPC, Plasma, RBC Set, Catalog number 80490 and 80491 RECALL NUMBER # B-0664-08 CODE Lot numbers: 03N0005, 04NXXXXX, 05NXXXXX, 06NXXXXX, 07N15247; 03N0006, 04NXXXXX, 05NXXXXX, 06NXXXXX, 07N15246; 04NXXXXX, 05NXXXXX, 06NXXXXX; 03N15290, 04NXXXXX, 05NXXXXX, 06NXXXXX, 07N15245, 07N15306. 04NXXXXX, 05NXXXXX, 07N15228; 03N15288, 03N15289, 04NXXXXX, 05NXXXXX, 06NXXXXX, 07N15216. 04NXXXXX, 05NXXXXX, 07N15244; 04NXXXXX, 05NXXXXX. 777800100. 03N1116, 03N1121, 03N1126, 03N2116, 03N3116, 03N3120, 03N3126, 03N3230, 04NXXXX, 05NXXXX, 06NXXXX, 07N1118, 07N2105, 07N2113, 07N2116, 07N2203, 07N2224, 07N3102, 07N3112, 07N3117, 07N3119, 07N3124, 07N3126, 07N3131, 07N3226, 07N3230; 04NXXXX, 05NXXXX, 06NXXXX, 07N9101, 07N9102, 08N9101; 03N3128, 04NXXXX, 05NXXXX, 06NXXXX, 07N3116. 04NXXXX, 05NXXXX, 06NXXXX, 07N3105; 07N9104; 03N3130, 04NXXXX, 05NXXXX, 07N3213. 03N0002, 03N1003, 03N1004, 03N2123, 04NXXXX, 05NXXXX, 06NXXXX, 07N2110, 07N2112, 07N2124. 03N2129, 03N3124, 04NXXXX, 05NXXXX. 06NXXXX, 07N3111, 07N3118, 07N3123. 05NXXXX, 06NXXXX; 06NXXXX, 05NXXXX, 06NXXXX. 05NXXXX. 04NXXXX, 06NXXXX, 07N2219, 07N3109, 07N3205; 03N2119, 03N2121, 03N2122, 03N2127, 03N2128, 03N2226, 04NXXXX, 05NXXXX, 06NXXXX, 07N1111, 07N1116, 07N1123, 07N2126. 03N3121, 05NXXXX, 07N3313. 04NXXXX, 06NXXXX. 05NXXXX; 05NXXXX. 03N3123, 04NXXXX, 06NXXXX, 07N3113; 03N9102, 04NXXXX, 06NXXXX, 07N9103 MANUFACTURED & RECALLED BY Gambro BCT, Inc., Lakewood, CO QUANTITY 582,558 sets DISTRIBUTION Nationwide and Internationally REASON Secondary platelet collection bags, which may have an inadequate weld, possibly allowing a small leak, were distributed. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT Vegetable Products in #10 can (6 to & pound cans) a) Classic Sysco brand, Distributed by Sysco Corporation, Houston, TX.Green asparagus cuts & tips (asparagus, water, salt) in 101 oz. (6 lb. 5 oz.) cans (UPC 7486510471). All lot codes beginning with "00249" are included. Great Northern beans (Great Northern beans, water, salt, calcium chloride, EDTA) in 108 oz. (6 lb. 12 oz.) cans (UPC 7486510486). All lot codes beginning with "00249" or "NORTH" are included. b) Green beans, Italian cut, (Italian green beans, water, salt), in 105 oz. (6 lb. 9 oz.) cans (UPC 7486511294). All lot codes beginning with "00249" or "ITAL" are included. c) Light red kidney beans (kidney beans, water, corn sweetener, salt, calcium chloride, EDTA) in 108 oz. (6 lb. 12 oz.) cans (UPC 7486510642). All lot codes beginning with "00249" or "LRKID" are included. d) Red beans (red beans, water, salt, calcium chloride, EDTA) in 110 oz. (6 lb. 14 oz.) cans (UPC 7486510638). All lot codes beginning with "00249" or "RED" are included. e) Cut wax beans (wax beans, water, salt) in 101 oz. (6 lb. 5 oz.) cans (UPC 7486511434). All lot codes beginning with "00249" or "WAX" are included. Code brand, Distributed by Code, Atlanta, GA. f) Dark red kidney beans (soaked kidney beans, water, corn sweetener, salt, calcium chloride, EDTA) in 6 lb. 12 oz. cans (UPC 1207316042). All lot codes beginning with "00249" or "DRKID" are included. g) Fancy cut wax beans 4 sieve (wax beans, water, salt) in 6 lb. 5 oz. cans (UPC 1207310183). All lot codes beginning with "00249" or "WAX" are included. Frosty Acres Restaurant's Pride Preferred brand, Packed for F.A.B., Inc., Alpharetta, GA. h) Black beans (cooked black beans, water, ferrous gluconate, calcium chloride) in 6 lb. 15 oz. cans (UPC 4820049145). All lot codes beginning with "00249" or "BLACK" are included. i) Blackeye Peas (Blackeye peas, water, salt, calcium chloride, EDTA) in 6 lb. 12 oz. cans (UPC 4820049146). All lot codes beginning with "00249" or "BEP" are included. j) Fancy Great Northern beans (Great Northern white beans, water, salt, natural flavors and calcium chloride) in 110 oz. (6 lb. 14 oz.) cans (UPC 4820068288). All lot codes beginning with "00249" or "NORTH" are included. k) Fancy cut Italian green beans (Italian beans, water, salt) in 105 oz. (6 lb. 9 oz.) cans (UPC 4820068390). All lot codes beginning with "00249" or "ITAL" are included. l) Fancy dark red kidney beans (dark red kidney beans, water, corn syrup, salt, calcium chloride) in 111 oz. (6 lb. 15 oz.) cans (UPC 4820068171). All lot codes beginning with "00249" or "DRKID" are included. m) Fancy Mexican style chili beans (white beans, water, corn syrup, sugar, tomato paste, salt, dextrose, onion powder, garlic powder, oleoresin paprika, natural flavors) in 111 oz. (6 lb. 15 oz.) cans (UPC 4820068534). All lot codes beginning with "00249" or "CHILI" are included. n) Fancy pinto beans (pinto beans, water, salt, calcium chloride, EDTA) in 111 oz. (6 lb. 15 oz.) cans (UPC 4820068939). All lot codes beginning with "00249" or "PINTO" are included. o) Fancy red beans (prepared red beans, water, salt, calcium chloride, EDTA) in 6 lb. 12 oz. cans (UPC 4820069023). All lot codes beginning with "00249" or "RED" are included. p) Fancy vegetarian beans in tomato sauce (white beans, water, corn syrup, sugar, tomato paste, salt, dextrose, onion powder, garlic powder, oleoresin paprika and natural flavorings) in 112 oz (7 lb.) cans (UPC 4820069161). All lot codes beginning with "00249" or "VEG" are included. GFS brand, Distributed by Gordon Food Service, Grand Rapids, MI q) Fancy all green asparagus cuts & tips (asparagus, water, salt) in 6 lb. 5 oz. cans, reorder no. 229601 (UPC 9390122960). All lot codes beginning with "00249" are included. r) Fancy black beans (black beans, water, salt) in 6 lb. 12 oz. cans, reorder no. 557714 (UPC 9390155771). All lot codes beginning with "00249" or "BLACK" are included. s) Italian cut green beans (Italian green beans, water, salt) in 6 lb. 9 oz. cans, reorder no. 769878 (UPC 9390176987). All lot codes beginning with "00249" or "ITAL" are included. t) Medium lima beans (lima beans, water, salt) in 6 lb. 12 oz. cans, reorder no. 118796 (UPC 9390111879). All lot codes beginning with "00249" or "LIMA" are included. u) Fancy Mexican style chili beans (soaked red beans, water, chili seasoning, salt, corn starch, tomato paste, sugar, calcium chloride) in 6 lb. 12 oz. cans, reorder no. 192015 (UPC 9390119201). All lot codes beginning with "00249" or "CHILI" are included. v) Fancy cut wax beans 4 sieve (wax beans, water, salt) in 6 lb. 5 oz. cans, 118834 (UPC 9390111883). All lot codes beginning with "00249" or "WAX" are included. Kitchen Essentials brand, Distributed by Gordon Food Service, Grand Rapids, MI. w) Cut wax beans mixed sieve (wax beans, water, salt) in 6 lb. 5 oz. cans, 274453 (UPC 9390127445). All lot codes beginning with "00249" or "WAX" are included. Monarch Heritage brand, Packed for PYA/Monarch, Inc, Greenville, SC. x) Italian style cut green beans (green beans, water, salt) in 6 lb. 5 oz. cans, 173865 (No UPC code). All lot codes beginning with "00249" or "ITAL" are included. Necco brand, Packed by New Era Canning Company, New Era, MI. y) Cut wax beans (wax beans, water, salt) in 6 lb. 6 oz. cans (UPC 3683513440). All lot codes beginning with "00249" or "WAX" are included. New Era brand, Distributed by New Era Canning Co, New Era, MI. z) Asparagus cuts & spears (asparagus, water, salt) in 108 oz. (6 lb. 12 oz.) cans (UPC 3683511220). All lot codes beginning with "00249" are included. aa) Black beans (black beans, water, salt) in 108 oz. (6 lb. 12 oz.) cans (UPC 3683511692). All lot codes beginning with "00249" or "BLACK" are included. bb) Black-eyed peas (black-eye peas, water, salt, calcium chloride, EDTA) in 108 oz. (6 lb. 12 oz.) cans (UPC 3683511698). All lot codes beginning with "00249" or "BEP" are included. cc) Butter beans (lima beans, water, salt, sugar, calcium chloride, EDTA) in 108 oz. (6 lb. 12 oz.) cans (UPC 3683511694). All lot codes beginning with "00249" or "LIMA" are included. dd) Chili beans in 108 oz. (6 lb. 12 oz.) cans (UPC 3683511675). All lot codes beginning with "00249" or "CHILI" are included. ee) Great Northern beans (Great Northern beans, water, salt, calcium chloride, EDTA) in 110 oz. (6 lb. 14 oz.) cans (UPC 3683511688). All lot codes beginning with "00249" or "NORTH" are included. ff) Italian Cut Green Beans (Italian beans, water, salt) in 108 oz. (6 lb. 12 oz.) cans (UPC 3683511342). All lot codes beginning with "00249" or "ITAL" are included. gg) Light red kidney beans, (kidney beans, water, corn sweetener, salt, calcium chloride, EDTA) in 108 oz. (6 lb. 12 oz.) cans (UPC 3683511682). All lot codes beginning with "00249" or "LRKID" are included. hh) Dark red kidney beans, (kidney beans, water, corn sweetener, salt, calcium chloride, EDTA) in 108 oz. (6 lb. 12 oz.) cans (UPC 3683511680). All lot codes beginning with "00249" or "DRKID" are included. ii) Lima beans (lima beans, water, salt) in 108 oz. (6 lb. 12 oz.) cans (UPC 3683511696). All lot codes beginning with "00249" or "LIMA" are included. jj) Pinto beans (pinto beans, water, salt, calcium chloride, EDTA) in 108 oz. (6 lb. 12 oz.) cans (UPC 3683511686). All lot codes beginning with "00249" or "PINTO" are included. kk) Red beans (red beans, water, salt) in 6 lb. 12 oz. cans (no UPC). All lot codes beginning with "00249" or "RED" are included. ll) Vegetarian beans (white beans, water, cane syrup, tomato paste, corn syrup, salt, vinegar, calcium chloride, onion powder, paprika, spice, natural flavorings) in 108 oz. (6 lb. 12 oz.) cans (UPC 3683511670). All lot codes beginning with "00249" or "VEG" are included. mm) Cut wax beans (wax beans, water, salt) in 102 oz. (6 lb. 6 oz.) cans (UPC 3683511440). All lot codes beginning with "00249" or "WAX" are included. Nugget brand, Distributed by Nugget, Atlanta, GA. nn) Asparagus cuts & tips (asparagus, water, salt) in 6 lb. 12 oz. cans, (UPC 4410503580). All lot codes beginning with "00249" are included. Reliance Sysco, Distributed by Sysco Corporation, Houston, TX. oo) Cut wax beans 4 sieve (wax beans, water, salt) in 6 lb. 5 oz. cans, 4108056 (UPC 7486512190). All lot codes beginning with "00249" or "WAX" are included. pp) Wax beans mixed and short cuts (wax beans, water, salt) in 6 lb. 5 oz. cans, 4182788 (UPC 7486512231). All lot codes beginning with "00249" or "WAX" are included. RECALL NUMBER Not available at the time of this publication CODE All #10 cans MANUFACTURED & RECALLED BY New Era Canning Company, New Era, MI QUANTITY Unknown at the time of this publication DISTRIBUTION Nationwide REASON Can may have been processed under conditions which could have led to contamination by Clostridium botulinum bacterium spores, which can cause life-threatening illness or death. NOTE No product has tested positive for the toxin and have been no cases of botulism reported from these products. This recall only affects products in #10 cans. CONTACT New Era Canning at 1-9=800-282-9007 ext 111 --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT 1) Non-Aspirin Pain Reliever/Fever Reducer, Acetaminophen, 325 mg RECALL NUMBER # D-098-2008 PRODUCT 2) Maximum Strength Nasal Decongestant PE, Phenylephrine Hydrochloride 10 mg RECALL NUMBER # D-099-2008 PRODUCT 3) Nasal Decongestant, Pseudoephedrine Hydrochloride, 30 mg RECALL NUMBER # D-100-2008 PRODUCT 4) Nasal Decongestant/Antihistamine, Pseudoephedrine Hydrochloride 60 mg and Triprolidine Hydrochloride 2.5 mg RECALL NUMBER # D-101-2008 PRODUCT 5) Antihistamine, Chlorpheniramine Maleate, 4 mg, 100 tablets RECALL NUMBER # D-102-2008 PRODUCT 6) Extra Strength Non-Aspirin Gelatin Tablets, Acetaminophen, 325 mg RECALL NUMBER # D-103-2008 PRODUCT 7) Extra Strength Non-Aspirin Gelatin Tablets, Acetaminophen 500 mg RECALL NUMBER # D-104-2008 PRODUCT 8) Aspirin Free Headache PM, Acetaminophen 500 mg and Diphenhydramine Citrate 38 mg RECALL NUMBER # D-105-2008 PRODUCT 9) Aspirin Pain Reliever/Fever Reducer, 325 mg RECALL NUMBER # D-106-2008 PRODUCT 10) Aspirin, (Enteric Coated)/Pain Reliever/Fever Reducer, 325 mg RECALL NUMBER # D-107-2008 PRODUCT 11) Allergy Medication, Diphenhydramine Hydrochloride 25 mg RECALL NUMBER # D-108-2008 PRODUCT 12) Pain Reliever/Fever Reducer (NSAID), Ibuprofen USP, 200 mg RECALL NUMBER # D-109-2008 PRODUCT 13) Stool Softener, Docusate Sodium 100 mg RECALL NUMBER # D-110-2008 PRODUCT 14) Nighttime Sleep-Aid, Diphenhydramine Hydrochloride 25 mg RECALL NUMBER # D-111-2008 PRODUCT 15) Maximum Strength Nighttime Sleep-Aid, Diphenhydramine Hydrochloride USP 50 mg RECALL NUMBER # D-112-2008 PRODUCT 16) Extra Strength Non-Aspirin PM, Acetaminophen 500 mg RECALL NUMBER # D-113-2008 PRODUCT 17) Low Strength Aspirin Regimen Enteric Coated, Aspirin 81 mg RECALL NUMBER # D-114-2008 PRODUCT 18) Anti-Diarrheal, Loperamide HCl Tablets USP, 2 mg RECALL NUMBER # D-115-2008 PRODUCT 19) Day-Time Cold/Flu Medicine Softgels, Pseudoephedrine Hydrochloride 30 mg, Acetaminophen 250 mg, Dextromethorphan Hydrobromide 10 mg RECALL NUMBER # D-116-2008 PRODUCT 20) Night-Time Cold/Flu Medicine Softgels, Doxylamine Succinate, 6.25 mg, Dextromethorphan Hydrobromide, 10 mg, Acetaminophen 250 mg, and Pseudoephedrine Hydrochloride 30 mg RECALL NUMBER # D-117-2008 PRODUCT 21) Fiber Laxative Caplets, Calcium Polycarbophil 625 mg equivalent to 500 mg polycarbophil, Bulk-forming laxative RECALL NUMBER # D-118-2008 PRODUCT 22) Multi-Symptom PMS Caplets, Premenstrual Symptom Reliever, Acetaminophen 500 mg, Pamabrom 25 mg, Pyrilamine Maleate 15 mg RECALL NUMBER # D-119-2008 PRODUCT 23) Natural Laxative Tablets (Standardized Senna Concentrate), Sennosides 8.6 mg RECALL NUMBER # D-120-2008 PRODUCT 24) Pain Reliever/Fever Reducer (NSAID), Naproxen sodium 220 mg RECALL NUMBER # D-121-2008 PRODUCT 25) Antacid Tablets/Calcium Supplement, Assorted Fruit Flavors, Naturally and Artificially Flavored, Manufactured and distributed in the following dosages: Calcium Carbonate USP 750 mg, Antacid * Calcium Carbonate USP 500 mg, Antacid * Calcium Carbonate USP 1000 mg RECALL NUMBER # D-122-2008 PRODUCT 26) Chocolated Stimulant Laxative, Sennosides USP, 15 mg RECALL NUMBER # D-123-2008 PRODUCT 27) Women's Laxative Tablets, Bisacodyl 5 mg, Stimulant laxative RECALL NUMBER # D-124-2008; PRODUCT 28) Cimetidine Tablets, USP, 200 mg, Acid reducer RECALL NUMBER # D-125-2008 PRODUCT 29) Acid Reducer, Ranitidine Tablets USP, 75 mg (as ranitidine hydrochloride USP 84 mg) RECALL NUMBER # D-126-2008 PRODUCT 30) Extra Strength, Non-Aspirin PM, Gelcaps, Acetaminophen 500 mg, and Diphenhydramine, Hydrochloride 25 mg, Pain reliever/Fever reducer and Sleep aid RECALL NUMBER # D-127-2008 PRODUCT 31) Allergy Medication Decongestant Capsule-Shaped Tablets, Diphenhydramine Hydrochloride 25 mg, Pseudoephedrine Hydrochloride 60 mg, Antihistamine/ Nasal Decongestant RECALL NUMBER # D-128-2008 PRODUCT 32) Acid Reducer, Famotidine Tablets USP, 10 mg RECALL NUMBER # D-129-2008 PRODUCT 33) Extra Strength Non-Aspirin Allergy Sinus Gelatin Caplets, Acetaminophen 500 mg, Chlorpheniramine maleate 2 mg, and Pseudoephedrine HCl 30 mg, Pain reliever/ Antihistamine Nasal decongestant RECALL NUMBER # D-130-2008 PRODUCT 34) Ibuprofen Liquid Softgels, Ibuprofen 200 mg, Pain reliever/fever reducer RECALL NUMBER # D-131-2008 PRODUCT 35) Ibuprofen Capsules, Ibuprofen 200 mg (NSAID), Pain reliever/fever reducer RECALL NUMBER # D-132-2008 PRODUCT 36) Non Drowsy* Allergy Relief, Loratadine 10 mg Tablets, Antihistamine RECALL NUMBER # D-133-2008 PRODUCT 37) Psyllium Fiber Capsules, 100% Natural Psyllium husk approximately 520 mg, Bulk forming laxative, Fiber Therapy for Regularity / Fiber Supplement RECALL NUMBER # D-134-2008; PRODUCT 38) Non-Drowsy 24-Hour Allergy & Congestion Relief Extended Release Tablets, Loratadine 10 mg and Pseudoephedrine sulfate 240 mg, Antihistamine/ Nasal decongestant RECALL NUMBER # D-135-2008 PRODUCT 39) Antihistamine Nasal Decongestant, Chlorpheniramine maleate 4 mg and Phenylephrine HCl 10 mg RECALL NUMBER # D-136-2008 PRODUCT 40) Maximun Strength, Sinus Headache PE, Acetaminophen 325 mg and Phenylephrine HCl 5 mg, Pain Reliever/Nasal Decongestant RECALL NUMBER # D-137-2008 PRODUCT 41) Cough Suppressant, Dextromethorphan HBr, 15 mg RECALL NUMBER # D-138-2008 PRODUCT 42) Cough Suppressant, Dextromethorphan HBr, 7.5 mg RECALL NUMBER # D-139-2008 PRODUCT 43) Children's Cough, Cold & Allergy Strips, Diphenhydramine Citrate 19 mg, Cough Suppressant/Antihistamine RECALL NUMBER # D-140-2008 PRODUCT 44) Children's Cough & Runny Nose, Diphenhydramine citrate 19 mg, Cough Suppressant/Antihistamine, Manufactured and distributed under the following Brand names: Meijer, Raspberry Flavored Medicated Strips RECALL NUMBER # D-141-2008 PRODUCT 45) Children's Allergy, Diphenhydramine citrate 19 mg, Antihistamine RECALL NUMBER # D-142-2008 PRODUCT 46) Pain Reliever/Fever Reducer/Nasal Decongestant, Ibuprofen 200 mg (NSAID) and Pseudoephedrine HCl 30 mg, nonsteroidal anti-inflammatory drug RECALL NUMBER # D-143-2008 PRODUCT 47) Pain Reliever/Nasal Decongestant, Acetaminophen 325 mg, Phenylephrine HCl 5 mg RECALL NUMBER # D-144-2008 PRODUCT 48) Pain Reliever/Fever Reducer, Antihistamine/Cough Suppressant, Nasal Decongestant, Acetaminophen 325 mg Diphenhydramine HCl 12.5 mg, Phenylephrine HCl 5 mg RECALL NUMBER # D-145-2008 PRODUCT 49) Cough & Cold, Antihistamine/Cough Suppressant, Decongestant-Free, For People with High Blood Pressure, Chlorpheniramine maleate 4 mg, Dextromethorphan HBr 30 mg RECALL NUMBER # D-146-2008 PRODUCT 50) Maximum Strength Menstrual Formula Caplets, Acetaminophen 500 mg, Caffeine 60 mg, Pyrilamine maleate 15 mg RECALL NUMBER # D-147-2008 PRODUCT 51) Pain Reliever, Antihistamine, Nasal Decongestant, Acetaminophen 325 mg, Diphenhydramine HCl 12.5 mg, Phenylephrine HCl 5 mg RECALL NUMBER # D-148-2008 PRODUCT 52) Daytime Cold/Flu PE Softgels, Multi-Symptom COLD/FLU Relief, Acetaminophen 325 mg, Dextromethorphan HBr 10 mg, Phenylephrine HCl 5 mg RECALL NUMBER # D-149-2008 PRODUCT 53) Nighttime Cold & Flu Softgels Multi-Symptom COLD/FLU Relief, Acetaminophen 325 mg, Dextromethorphan HBr 15 mg, Doxylamine Succinate 6.25 mg RECALL NUMBER # D-150-2008 PRODUCT 54) Extra Strength Acetaminophen 500 mg, Easy To Swallow Tabs, Pain reliever/fever reducer RECALL NUMBER # D-151-2008 PRODUCT 55) Maximum Strength, Famotidine Tablets, USP 20 mg RECALL NUMBER # D-152-2008 PRODUCT 56) Alertness Aid with Caffeine, Caffeine, 200 mg RECALL NUMBER # D-153-2008 PRODUCT 57) Backache Relief, Magnesium Salicylate, 467.2 mg RECALL NUMBER # D-154-2008 PRODUCT 58) Antacid, Gelatin Caplets, Calcium carbonate, 550 mg, Magnesium hydroxide, 125 mg RECALL NUMBER # D-155-2008 CODE All distributed OTC drug products that are still within expiration dating. MANUFACTURED & RECALLED BY Leiner Health Products, LLC Nw, Wilson, NC QUANTITY 148,836,257 units total DISTRIBUTION Nationwide and Canada REASON cGMP Deficiencies ---------------------------------------------------------------------------