NRAC Issue #1610 ADDENDUM December 26, 2006 --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT a) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber catheter. Latex Free A Port Ref Product No. AP-01007 RECALL NUMBER # Z-0270-2007 PRODUCT b) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Ref Product No. AP-01013 Latex-Free Low Profile Port RECALL NUMBER # Z-0271-2007 PRODUCT c) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free A(2) Port, 17 Fr. Introducer Kit REF Product No. AP-06535 RECALL NUMBER # Z-0272-2007 PRODUCT d) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free A(2) Port, 10 Fr. Introducer Kit Ref Product No. AP-06530 RECALL NUMBER # Z-0273-2007 PRODUCT e) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free A(2) Port, 12 Fr. Introducer Kit. Ref Product Code: AP-06528 RECALL NUMBER # Z-0274-2007 PRODUCT f) Implantable Vascular Access system -- Infusion Ports with Silicone Rubber Catheter. Latex-Free A Port, 10 Fr. Introducer Kit. Ref Product No. AP-06520 RECALL NUMBER # Z-0275-2007 PRODUCT g) Implantable Vascular Access system -- Infusion Ports with Silicone Rubber Catheter. Latex-Free Low Profile B Port, 6 Fr. Introducer Kit. Ref Product No. AP-06046 RECALL NUMBER # Z-0276-2007 PRODUCT h) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free Low Profile Port. 10 Fr. Introducer Kit. Ref Product No. AP-06042 RECALL NUMBER # Z-0277-2007 PRODUCT i) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free Low Profile Port. 9 Fr. Introducer Kit. Ref Product No. AP -06040 RECALL NUMBER # Z-0278-2007 PRODUCT j) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free Low Profile Port. 6 Fr. Introducer Kit Ref. Product No. AP-06036 RECALL NUMBER # Z-0279-2007 PRODUCT k) Implantable Vascular Access system -- Infusion Ports with Silicone Rubber Catheter. Latex-Free Low Profile Port. 10 Fr. Introducer Kit Ref Product No. AP-06022 RECALL NUMBER # Z-0280-2007 PRODUCT l) Implantable Vascular Access system -- Infusion Ports with Silicone Rubber Catheter. Latex-Free Low Profile Port. 9 Fr. Introducer Kit Ref Product No. AP-06020 RECALL NUMBER # Z-0281-2007 PRODUCT m) Implantable Vascular Access system --Infusion Ports with Silicone Rubber Catheter. Latex-free A Port. 9 Fr. Introducer Kit. Ref. Product No. AP-06018 RECALL NUMBER # Z-0282-2007 PRODUCT n) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free Low Profile Port. 6 Fr. Introducer Kit. Ref. Product No. AP-06016 RECALL NUMBER # Z-0283-2007 PRODUCT o) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-free A Port. 10 Fr. Introducer Kit. Ref. Product No. AP-06015 RECALL NUMBER # Z-0284-2007 PRODUCT p) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free A Port. 6 Fr. Introducer Kit. Ref Product No. AP-06014 RECALL NUMBER # Z-0285-2007 PRODUCT q) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free A Port. 9 Fr. Introducer Kit Ref Product No. AP-06013 RECALL NUMBER # Z-0286-2007 PRODUCT r) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free A Port. Ref Product No. AP-01510 RECALL NUMBER # Z-0287-2007 CODE a) Lot Numbers: MF2041118, MF2112625, MF3013201, MF3105944, MF4031465; b) Lot Numbers: 11284, MF3085483, MF4031500, MF4063259; c) Lot Numbers: MF3023376, MF3044179, MF3085273, MF3126313, MF4020636, MF6014780, MF6025930, MF6079639, MR2070141; d) Lot Numbers: 11750, 11999, 12059, MF4031397, MF4042081, MF4062934, MF4063103, MF4073794, MF5027702, MF5059738, MF5060177, MF5060656, MF5081903, MF5103211, MF6036473, MF6036909, MF6068938, MS3100148; e) Lot Number: 12054, MF3033635, MF3075166, MF3095536, MF3105900, MF3116038, MF4016607, MF4020455, MF4020838, MF4063175, MF4073793, MF4084293, MF4084406, MF4105408, MF5017415, MF5049326, MF6014778, MF6068936, MF6079334; f) Lot Number: MF1033516, MF2071649, MF2081937, MF2082002, MF2092208, MF2092278, MF2102373, MF2102462, MF2112595, MF2112688, MF2122960, MF3013060, MF3013065, MF3013198, MF3013279, MF3013308, MF3023367, MF3023427, MF3033567, MF3033642, MF3033732, MF3043847, MF3043910, MF3044134, MF3054228, MF3054338, MF3054447, MF3054465, MF3064645, MF3064763, MF3064833, MF3074927, MF3075118, MF3085281, MF3095491, MF3095574, MF3095611, MF3105931, MF3106006, MF3116245, MF3126277, MF3126278, MF3126318, MF3126396, MF3126417, MF3126450, MF4016582, MF4016635, MF4020551, MF4020553, MF4020806, MF4031020, MF4031582, MF4041771, MF4041936, MF4052333, MF4063058, MF4073792, MF4083964, MF4084041, MF4084292, MF4094582, MF4094706, MF4105124, MF4105261, MF4105486, MF4105803, MF4116118, MF5017414, MF5017549, MF5027701, MF5028033, MF5028158, MF5038602, MF5050176, MF5059737, MF5060355, MF5060468, MF5071341, MF5081670, MF5081671, MF5081762, MF5081870, MF5081902, MF5082122, MF5082249, MF5092841, MF5093006, MF5103341, MF5103508, MF5113683, MF5113875, MF5114153, MF5124319, MF5124528, MF6014777, MF6025871, MF6026069, MF6026200, MF6036711, MF6057765, MF6058113, MF6058190, MF6058298, MF6068660, MF6079304, MF6089737, MF6089985, MS3110155, MS3110156, MS3110157, MS3110158, MS4031056, MS4031058, MS4031059, MS4031065; g) Lot Number: MF2102346, MF2112623, MF2122946, MF3023531, MF3043934, MF3074943, MF3085287, MF3095692, MF4020550, MF4031019, MF4031353, MF4041638, MF4063174, MF4105485, MF5017413, MF5017546, MF5038769; h) Lot Numbers: 11916, MF2092169, MF2092256, MF3013079, MF3013159, MF3013315, MF3013320, MF3023358, MF3033614, MF3043940, MF3064659, MF3054234, MF3075086, MF3075140, MF3116147, MF3126395, MF4016579, MF4031049, MF4031484, MF4063059, MF4063266, MF4105260, MF4105483, MF4115980, MF4126889, MF4126890, MF5027945, MF5059894, MF5060175, MF5092679, MF5103210, MF5113791, MF5124527, MF6015496, MF6025735, MF6026194, MF6057764, MF6080022, MR3110192, MR3110194, MS2100122, MS4041843, MS4041844, MS4041845; i) Lot Numbers: MF2082014, MF2092092, MF2102287, MF2122972, MF3023424, MF3033561, MF3033608, MF3054587, MF3074949, MF3075147, MF3085288, MF3085340, MF3095656, MF3095740, MF3105983, MF3126394, MF4016539, MF4031048, MF4031211, MF4031352, MF4041932, MF4062931, MF4063056, MF4083962, MF4084405, MF4126532, MF5017410, MF5038601, MF5050044, MF5059734, MF5081723, MF5124399, MF6015389, MF6025738, MF6026066, MF6047369, MF6047370, MF6025851, MF6057763; j) Lot Numbers: MF2081824, MF2092267, MF3013206, MF3023468, MF3033568, MF3043935, MF3054360, MF3054525, MF3126300, MF4016726, MF4031047, MF4042099, MF4062964, MF4105288, MF4105802, MF4126773, MF5027944, MF5038765, MF5070950, MF5124151, MF6014960, MF6036562, MF6047448, MF6058105, MF6058348, MF6036931, MF6068655; k) Lot Numbers: 12025, 12026, MF2082053, MF2092149, MF2102348, MF2112612, MF2112798, MF2122887, MF3013239, MF3023441, MF3033609, MF3033767, MF3043953, MF3054471, MF3054551, MF3064671, MF3064720, MF3074950, MF3075080, MF3085227, MF3085410, MF3106022, MF3126356, MF3116146, MF4020300, MF4020624, MF4031189, MF4041636, MF4041931, MF4052351, MF4063054, MF4063107, MF4063265, MF4073781, MF4073838, MF4105285, MF4105479, MF4105680, MF4126531, MF4126772, MF4126885, MF5017407, MF5028155, MF5038764, MF5050041, MF5059731, MF5059893, MF5060649, MF5081721, MF5082121, MF5092678. MF5103209, MF5103504, MF5113992, MF5114145, MF5124303, MF6015495, MF6036710, MF6047367, MF6047368, MF6057762, MF6058411, MF6068650, MS3110150, MS4041840; l) Lot Numbers: MF1075363, MF2071759, MF2071795, MF2081849, MF2081900, MF2122871, MF2122962, MF3013303, MF3023498, MF3033750, MF3054449, MF3054482, MF3085186, MF3085246, MF3085395, MF3095548, MF3116233, MF3116244, MF4020723, MF4020901, MF4031014, MF4031015, MF4031466, MF4052331, MF4062929, MF4063264, MF4084283, MF4094580, MF4094705, MF4105328, MF4105577, MF4115963, MF4126528, MF4126656, MF4126883, MF4126884, MF5017406, MF5027697, MF5028032, MF5028154, MF5038599, MF5050172, MF5059730, MF5059892, MF5060353, MF5060465, MF5070948, MF5081719, MF5081720, MF5124397, MF5082119, MF5092548, MF5103503, MF5103681, MF5113874, MF5124524, MF6014999, MF6047362, MF6047363, MF6047523, MF6057740, MF6057761, MF6068649, MF6068928, MF6079295, MF6079297; m) Lot Numbers: MF2071557, MF2081915, MF2112752, MF3013138, MF3013309, MF3043927, MF3054236, MF3054472, MF3054594, MF3074941, MF3075061, MF3085480, MF3095763, MF3116074, MF3116187, MF4016702, MF4016725, MF4020805, MF4031013, MF4031188, MF4031373, MF4052203, MF4063052, MF4073779, MF4073837, MF4094885, MF4105259, MF4105799, MF4126881, MF5017404, MF5028031, MF5038301, MF5038425, MF5038760, MF5049322, MF5059729, MF5059889, MF5060171, MF5081718, MF5103002, MF5103502, MF5113789, MF5113991, MF6014861, MF6014998, MF6036561, MF6036618, MF6058293, MF6058347, MF6068925; n) Lot Numbers: MF2092160, MF2092258, MF4031012, MF4041798, MF4063372, MF4073836, MF4105283, MF6015284, MF6026177; o) Lot Number: 11953, 12024, 12048, MF2122834, MF2122873, MF3013094, MF3023399, MF3033565, MF3033661, MF3043929, MF3044026, MF3044155, MF3054297, MF3054407, MF3064741, MF3074954, MF3085360, MF3106021, MF4016605, MF4020460, MF4031011, MF4031501, MF4041930, MF4062927, MF4063051, MF4073944, MF4094579, MF4094883, MF4095027, MF4116113, MF4126523, MF5017401, MF5049107, MF5049320, MF5059727, MF5060170, MF5060348, MF5060463, MF5081716, MF5082118, MF5082247, MF5113788, MF5113989, MF5124143, MF6014773, MF6025691, MF6036470, MF6036928, MF6047447, MF6057759, MF6058188, MF6068647, MF6079327, MS3110160, MS4073806; p) Lot Numbers: 12130, 12134, MF3074955, MF3075069, MF3116186, MF3116232, MF3126390, MF4020623, MF4073774, MF4094578, MF4094703, MF4126653, MF5049105, MF5050037, MF5092675, MF5103680, MF6014995, MF6079156, MF6089978; q) Lot Numbers: MF2102345, MF2112624, MF2122835, MF3013200, MF3023408, MF3023552, MF3033766, MF3054406, MF3074987, MF3075143, MF3095708, MF3105784, MF3116130, MF3116231, MF4016530, MF4020444, MF4020470, MF4041797, MF4062926, MF4073773, MF4084282, MF4094881, MF4116112, MF4126522, MF4126770, MF4126879, MF5017542, MF5028152, MF5038758, MF5049103, MF5059726, MF5060460, MF5081715, MF5082408, MF5092546, MF5103679, MF5113983, MF6014772, MF6026163, MF6036927; r) Lot Numbers: MF2061389, MF2071761, MF2082058, MF2122799, MF2122869, MF3013124, MF3023533, MF3033713, MF3044092, MF3044143, MF3054233, MF3054527, MF3064662, MF3064871, MF3085292, MF3085315, MF3095651, MF3116183, MF3116212, MF3126476, MF4016721, MF4020469, MF4020739, MF4105255, MF5017539, MF5081888, MF6068638, MS3110153, MS4041605, MS4041616, MS4041617, MS4041618 MANUFACTURER Arrow International, Inc., Mount Holly, NJ RECALLED BY Arrow International Inc., Reading, PA QUANTITY 10,594 devices DISTRIBUTION Nationwide REASON Catheter has separated from the infusion port body. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT Amplatzer Cardiac Septal Occluder Delivery Systems labeled as follows: a) AMPLATZER Delivery System, Order no. 9-DEL-5F-180/60, 9-DEL-6F-45/60, 9-DEL-6F-180/80, 9-DEL-7F-45/60, 9-DEL-7F-45/80, 9-DEL-7F-180/80, 9-DEL-8F-45/60, 9-DEL-8F-45/80, 9-DEL-8F-180/80, 9-DEL-9F-45/80, 9-DEL-9F-180/80, 9-DEL-10F-45/80, 9-DEL-12F-45/80. [Breakdown of order no. '9-DEL-5F-180/60' is as follows: 9-DEL, French size (5F) - degree angle curve (180) / usable length in cm (60).] b) the following devices are not approved for US distribution: AMPLATZER TorqVue Delivery System, order no. 9-ITV06F45/60, 9-ITV07F45/60, 9-ITV07F45/80, 9-ITV08F45/60, 9-ITV08F45/80, 9-ITV09F45/80, 9-ITV10F45/80, 9-ITV12F45/80, 9-ITV05F180/60, 9-ITV06F180/80, 9-ITV07F180/80, 9-ITV08F180/80, 9-ITV09F180/80. The Delivery System is comprised of a delivery sheath, delivery cable, dilator, loading device and pin vise. RECALL NUMBER # Z-0255-2007 PRODUCT Amplatzer Cardiac Septal Occluder delivery system Exchange Systems labeled as follows: a) AMPLATZER Exchange System, Order no. 9-EXCH-6F-180/80, 9-EXCH-8F-180/80, 9EXCH-9F-45/80, 9-EXCH-12F-45/80. [Breakdown of order no. '9-EXCH-6F180/80' is as follows: 9-EXCH, French size (6F) - degree angle curve (180) / usable length in cm (80).] and b) the following devices are not approved for US distribution: AMPLATZER TorqVue Exchange System, Order no. 9-EITV09F45/80, 9-EITV12F45/80, 9-EITV06F180/80, 9-EITV08F180/80. The Exchange System is comprised of a delivery sheath, delivery cable, dilator, loading device and pin vise. RECALL NUMBER # Z-0256-2007 PRODUCT AMPLATZER TorqVue (cardiac Septal Occluder) Delivery System with Pusher Catheter Order no. 9-TVSP7F-180/80, 9-TVSP8F-180/80, 9-TVSP9F-180/80. [Breakdown of order no. '9-TVSP-7F-180/80' is as follows: 9-TVSP, French size (7F) - degree angle curve (180) / usable length in cm (80).] Sterile EO. Single Use Only. CAUTION: Investigational device limited by U.S. Law to Investigational Use. The AMPLATZER TorqVue Delivery System with Pusher Catheter consists of a radiopaque delivery sheath, translucent loading device, dilator, plastic vise, delivery cable, and pusher catheter. The delivery system also includes a high pressure Hemostasis valve with a swivel luer connector. The loading device, also with a full thread swivel luer connector, allows a positive fit and seal between sheath and loader. The translucent loader allows for visualization of the device and potentially the presence of air during transfer of device to the sheath. RECALL NUMBER # Z-0257-2007 CODE a) Order no. 9-DEL-5F-180/60, Lot Numbers: M03J19-05, M03L18-49, M04B02-02, M04C01-19, M04E18-13, M04J13-15, M04L02-04, M04M28-10, M05C15-31, M05C25-27, M05D29-51, M05G20-44, M05G28-19, M05H30-45, M05J23-32. Order no. 9-DEL-6F-45/60, Lot Numbers: M03L11-45, M03J23-04, M04B09-16, M04E27-19, M04L22-12, M05A03-10, M05B04-20, M05B08-04, M05C08-23, M05C09-05, M05E24-48, M05H01-51, M05J12-16, M06C20-25, M06D03-02, M06D19-71, M06E22-46. Order no. 9-DEL-6F-180/80, Lot Numbers: M03K16-22, M03K28-33, M03L11-47, M03M02-09, M03M03-09, M03M12-18, M04A19-31, M04B03-10, M04C01-17, M04C23-12, M04D06-10, M04D13-16, M04E24-16, M04F23-21, M04F28-40, M04G01-22, M04G27-27, M04H03-17, M04H12-11, M04H24-23, M04L08-02, M04M16-21, M04M30-04, M05A03-09, M05A05-27, M05A12-07, M05A17-07, M05A18-04, M05A20-09, M05A27-27, M05A31-06, M05B02-26, M05B21-13, M05B23-09, M05C08-04, M05C25-02, M05D07-08, M05D13-09, M05D14-13, M05G07-20, M05G11-03, M05G12-06, M05G15-24, M05G15-31, M05G27-41, M05H08-19, M05H04-10, M05H05-29, M05H09-09, M05K14-06, M05K20-10, M05K28-02, M05M28-23, M06A13-17, M06D19-53, M06D19-57, M06D19-55, M06D19-59, M06E16-68, M06E22-65, M06E22-67, M06F07-90, M06F13-86. Order no. 9-DEL-7F-45/60, Lot Numbers: . Order no., Lot Numbers: M03L12-09, M04C23-09, M04E24-17, M04G01-24, M04M10-18, M05B04-18, M05B07-06, M05B16-02, M05D08-09, M05F13-11, M05G15-16, M05G19-24, M05J08-03. Order no. 9-DEL-7F-45/80, Lot Numbers: M03J19-07, M03K14-06, M03K28-35, M03L11-48, M04B03-09, M04B03-14, M04C08-12, M04D06-12, M04E11-28, M04E24-20, M04F08-23, M04H03-23, M04J17-07, M04K07-02, M04K28-06, M04L30-04, M05A11-12, M05A11-10, M05A12-05, M05B04-09, M05B16-04, M05B16-23, M05B23-07, M05C10-07, M05C14-07, M05C15-29, M05D04-15, M05E03-02, M05E12-16, M05E12-03, M05E16-21, M05E17-45, M05F01-02, M05F30-25, M05G07-02, M05G21-06, M05G29-23, M05H01-11, M05H17-09, M05J16-13, M05J16-68, M05J28-08, M05K04-04, M05M05-11, M06A13-19, M06C20-23, M06C28-42, M06D04-77, M06D12-20, M06E16-80, M06F01-43, M06F07-88, M06F13-76, M06G25-96. Order no. 9-DEL-7F-180/80, Lot Numbers: M03K24-14, M03L12-10, M03M12-19, M03G15-34, M04B03-08, M04B09-17, M04C01-18, M04D01-05, M04D06-11, M04D20-07, M04E04-05, M04F08-21, M04H03-18, M04H24-25, M04K22-13, M04L30-12, M04M13-05, M05A18-26, M05A20-11, M05B08-06, M05B14-22, M05B18-10, M05B18-12, M05C16-33, M05C16-18, M05D05-39, M05E11-30, M05E18-04, M05E26-23, M05G08-07, M05G15-29, M05G26-16, M05H02-22, M05H03-11, M05J13-14, M05J19-66, M05J23-07, M05J26-19, M05K19-04, M05L30-22, M05M22-20, M06D19-67, M05D19-69, M06E16-76, M06E22-71, M06E22-69. Order no. 9-DEL-8F-45/60, Lot Numbers: M03K14-07, M03L18-50, M03M03-11, M04C23-10, M04E24-18, M04G01-20, M04L30-02, M04M15-20, M05B07-08, M05B14-04, M05B15-07, M05B24-14, M05B25-06, M05H19-13. Order no. 9-DEL-8F-45/80, Lot Numbers: M03J19-08, M03J25-27, M03K09-23, M03K28-36, M03L11-46, M03M03-12, M03M29-07, M04A19-28, M04A28-16, M04B03-13, M04B09-19, M04B17-33, M04B24-08, M04C23-11, M04D06-13, M04D26-06, M04D26-10, M04F08-22, M04F27-47, M04H24-22, M04J07-09, M04J10-22, M04J17-08, M04J17-09, M04K06-02, M04K11-08, M04K15-10, M04K25-25, M04L02-02, M04L08-12, M04L29-18, M04M01-02, M04M10-08, M04M20-16, M04M22-02, M04M30-05, M05A11-08, M05A18-28, M05A21-20, M05A21-24, M05A24-34, M05A27-13, M05A28-13, M05A31-08, M05B17-04, M05B17-06, M05C21-24, M05C24-04, M05C25-18, M05C30-24, M05C31-28, M05D06-07, M05D12-03, M05D14-09, M05D20-06, M05D25-19, M05D27-20, M05D28-13, M05E24-17, M05E25-21, M05E27-46, M05F06-46, M05F21-43, M05F21-41, M05G20-10, M05G27-39, M05H12-16, M05H17-13, M05H24-19, M05J09-10, M05J09-12, M05K11-03, M05K18-10, M05K20-08, M05K21-05, M05L17-19, M05L21-04, M05L28-04, M05L30-20, M06A09-15, M06A12-10, M06A12-12, M06A20-25, M06A20-27, M06A24-18, M06A20-29, M06C17-36, M06C17-38, M06D04-73, M06D11-05, M06D12-12, M06D12-14, M06D12-16, M06D12-18, M06E22-49, M06E22-51, M06F01-47, M06F07-82, M06F07-84, M06F07-86, M06F13-72, M06F13-74, M06F22-19, M06F29-12, M06G24-46. Order no. 9-DEL-8F-180/80, Lot Numbers: M03L18-52, M04B09-18, M04C23-13, M04E27-20, M04F08-24, M04H03-20, M04K26-18, M04L04-17. M05B11-08, M05C01-06, M05C01-08, M05C11-02, M05E02-21, M05F28-12, M05J01-38, M05J22-28, M05K18-04. Order no. 9-DEL-9F-45/80, Lot Numbers: M03K14-08, M03K24-15, M03K28-37, M03M02-12, M03M03-08, M03M29-03, M03M29-06, M03M30-13, M04A19-29, M04A28-18, M04B03-12, M04B17-38, M04C08-13, M04C15-04, M04C15-06, M04D06-09, M04D13-17, M04D20-08, M04D26-07, M04D26-09, M04E24-19, M04E27-24, M04F21-43, M04F23-23, M04G27-25, M04H12-12, M04H24-20, M04J22-13, M04K08-02, M04L05-08, M04L19-11, M04L29-02, M04L29-17, M04L29-23, M04L30-10, M04M14-02, M04M14-04, M04M14-21, M04M16-23, M04N22-23, M05A05-25, M05A03-12, M05A11-06, M05A13-19, M05A18-24, M05A19-04, M05A24-09, M05A24-32, M05A24-36, M05A25-19, M05A28-11, M05B01-05, M05B02-24, M05B04-22, M05B10-05, M05B11-06, M05B22-03, M05B23-05, M05B24-20, M05C10-25, M05C15-27, M05C24-02, M05D04-13, M05D06-05, M05D07-04, M05D08-11, M05D12-20, M05D26-26, M05E11-14, M05E11-16, M05E13-09, M05E31-04, M05E31-10, M05E31-12, M05F06-44, M05F03-12, M05F09-06, M05F10-07, M05F14-26, M05F16-17, M05F27-06, M05F29-06, M05G06-07, M05G18-30, M05G19-15, M05G27-07, M05G27-43, M05H01-09, M05H12-14, M05H18-34, M05H19-08, M0530-36, M05J07-10, M05J08-05, M05J16-57, M05L01-02, M05L18-02, M05L30-06, M05M02-21, M05M06-13, M05M08-16, M05M22-12, M05M22-16, M06A09-12, M06A16-23, M06C15-52, M06C20-27, M06C24-22, M06D04-69, M06D04-71, M06D19-61, M06D19-63, M06D21-03, M06D21-05, M06D21-07, M06E22-53, M06E22-55, M06F13-78, M06F29-10, M06G25-93. Order no. 9-DEL-9F-180/80, Lot Numbers: M03K28-34, M03L18-51, M04L22-14, M05C28-12, M05D07-10, M05E03-13, M05F22-09, M05J26-21. Order no. 9-DEL-10F-45/80, Lot Numbers: M03J25-26, M03K01-02, M03K09-22, M03K14-05, M03K16-16, M03K16-17, M03K24-09, M03L18-56, M03M30-11, M03M30-14, M03M30-15, M04A19-30, M04B03-11, M04B17-34, M04B24-09, M04C30-08, M04F08-20, M04F23-20, M04F28-46, M04G01-19, M04G01-21, M04H23-20, M04H23-21, M04J07-04, M04L29-19, M04L29-20, M04M22-25, M04M17-19, M04M29-09, M04M29-10, M05A03-11, M05A10-07, M05A10-09, M05A14-08, M05B07-24, M05B07-25, M05B07-26, M05B18-06, M05B21-04, M05B24-08, M05C03-08, M05C07-06, M05C10-05, M05C10-27, M05C15-25, M05C23-07, M05C29-13, M05D29-05, M05E04-17, M05E05-24, M05E09-19, M05E09-21, M05E16-19, M05E17-43, M05E24-13, M05E27-38, M05E26-33, M05F09-08, M05F28-08, M05F28-10, M05H03-37, M05H22-06, M05H25-15, M05H25-13, M05J01-13, M05J22-23, M05K10-07, M05K13-04, M05K19-02, M05K21-03, M05L18-04, M05L29-12, M05M02-23, M05M01-05, M05M22-18, M06A13-15, M06C15-55, M06C24-20, M06D04-65, M06D04-67, M06E08-10, M06E08-12, M06F07-80, M06F13-82, M06G25-94. Order no. 9-DEL-12F-45/80, Lot Numbers: M03J25-28, M03K16-21, M03K24-13, M03L18-55, M03M03-13, M03M30-12, M03M30-16, M04A28-19, M04C09-03, M04C09-04, M04C15-05, M04D01-04, M04D06-08, M04D26-08, M04F21-42, M04F23-22, M04G27-26, M04H03-22, M04H24-21, M04J30-02, M04K05-02, M04K25-23, M04L04-09, M04M10-05, M04M23-02, M05A13-03, M05A14-11, M05A19-06, M05B04-24, M05B21-28, M05C03-04, M05C02-06, M05C07-08, M05C08-02, M05C21-25, M05D07-06, M05D15-28, M05D19-02, M05D18-45, M05D25-04, M05D28-23, M05D29-19, M05E02-08, M05E10-29, M05E13-26, M05E19-07, M05E20-17, M05E24-15, M05F07-12, M05F15-35, M05F15-43, M05F20-05, M05F21-54, M05G13-16, M05G25-15, M05G27-09, M05H05-27, M05H26-08, M05H29-16, M05J09-27, M05J12-09, M05J12-07, M05K06-10, M05K07-25, M05K31-28, M06C15-57, M06D04-75, M06D12-10, M06E16-78, M06F01-45, M06F13-84. Tthe following devices are not approved for US distribution: AMPLATZER TorqVue Delivery System, order no. 9-ITV06F45/60, Lot numbers: M05K24-25, M05L03-06, M06C03-17, M06C27-05, M06E22-57. Order no. 9-ITV07F45/60, Lot numbers: M05K24-27, M05L04-13, M06B10-21, M06E01-40, M06F13-96. Order no. 9-ITV07F45/80, Lot numbers: M05K24-04, M05L10-07, M05L14-13, M05L15-34, M06B01-31, M06C02-14, M06F01-33, M06F07-68, M06F07-70. Order no. 9-ITV08F45/60, Lot numbers: M05K24-29, M05L03-08, M06B10-25. Order no. 9-ITV08F45/80, Lot numbers: M05K24-31, M05L11-15, M05M06-17, M05M07-10, M05M12-16, M06A05-25, M06B01-33, M06B10-27, M06B10-23, M06E03-10, M06E03-08, M06E16-84, M06F01-41, M06F13-90, M06G06-18, M06G25-79. Order no. 9-ITV09F45/80, Lot numbers: M05K24-33, M05L10-09, M05M12-18, M05M12-20, M06A12-19, M06B01-37, M06B10-29, M06C03-14, M06C10-18, M06C10-20, M06C13-38, M06C13-40, M06D19-73, M06D26-26, M06D26-28, M06D26-30, M06F01-39, M06F07-76, M06F07-72, M06F13-98, M06F14-03, M06F22-17, M06F14-01, M06G24-28, M06F22-15. Order no. 9-ITV10F45/80, Lot numbers: M05K24-06, M05L02-12, M05M07-12, M05M12-22. M06B01-39, M06C02-16, M06C10-22, M06C10-24, M06C13-42, M06C13-44, M06D12-08, M06D12-06, M06F13-92, M06G06-24, M06G06-22. Order no. 9-ITV12F45/80, Lot numbers: M05K24-35, M05L14-09, M05M05-15, M05M12-24, M06B01-41, M06C02-18, M06C20-39, M06C10-28, M06C10-26, M06D12-01, M06E03-04, M06E09-59, M06G25-89. Order no. 9-ITV05F180/60, Lot numbers: M05K24-02, M05L02-15, M06C27-07. Order no. 9-ITV06F180/60, Lot numbers: Order no. 9-ITV06F180/80, Lot numbers: M05K24-08, M05L03-10, M05L04-15, M05L17-23, M05L28-03, M06C20-29, M06C20-31, M06C27-08, M06C20-33, M06E01-05, M06G06-26. Order no. 9-ITV07F180/80, Lot numbers: M05K24-10, M05L08-06, M05L15-28, M05L17-25, M06B17-34, M06B21-43, M06B21-45, M06B21-47, M06G24-24. Order no. 9-ITV08F180/80, Lot numbers: M05K24-23, M05L11-17, M06B17-28, M06D19-65, M06E08-05. Order no. 9-ITV09F180/80, Lot numbers: M05K24-21, M05L07-06, M06B17-32; b) Order no. 9-EXCH6F-180/80, Lot Numbers: M05F10-13, M06F22-25. Order no. 9-EXCH8F-180/80, Lot numbers: M04D01-06, M04E27-21, M05C23-13. Order no. 9EXCH9F-45/80, Lot Numbers: M03L18-54, M05A12-09, M05D19-10, M05D18-47, M05E23-37, M05G15-06, M05H18-36. Order no. 9-EXCH12F-45/80, Lot Numbers: M05A13-23, M05B04-11, M05B14-08, M05C30-11, M05E02-19, M05H08-20. The following devices are not approved for US distribution: AMPLATZER TorqVue Exchange System, Order no. 9-EITV09F45/80, Lot numbers: M06A05-31, M05L15-24. Order no. 9-EITV12F45/80, Lot numbers: M06A05-33, M05L15-26. Order no. 9-EITV06F180/80, Lot numbers: M06D19-51. Order no. 9-EITV08F180/80, Lot numbers: M05L15-32, M06G26-02; c) Order no. 9-TVSP7F-180/80, Lot Numbers: M03K16-18, M03K24-10, M03K28-30, M03L06-36, M03L12-04, M03M02-10, M04B17-36, M04E18-12, M04E27-16, M04H31-16, M04L15-16, M05C09-09, M05C25-06, M05D20-17, M05E05-20, M05E23-39. Order no. 9-TVSP8F-180/80, Lot Numbers: M03J17-08, M03K16-19, M03K24-11, M03K28-31, M03L06-37, M03L12-05, M03M02-11, M03M30-10, M04B17-37, M04E27-17, M04L08-10, M05A13-05, M05C25-08, M05E05-07, M05F17-10. Order no. 9-TVSP9F-180/80, Lot Numbers: M03J17-09, M03K16-20, M03K24-12, M03K28-32, M03L06-38, M03L12-06, M04E27-18, M04H03-21, M04L15-18, M05D11-12, and M05D20-19. MANUFACTURED & RECALLED BY AGA Medical Corporation, Golden Valley MN QUANTITY 107,484 units DISTRIBUTION Nationwide and Internationally REASON AGA Medical has found that microscopic tears can occur in the delivery system sterile packaging under accelerated stress testing with routine shipping configurations. These microscopic tears are a potential breach of the sterile barrier. AGA has no confirmed complaints or adverse events related to this failure mode. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT Human Tissue for Transplantation a) Achilles Tendon (various sizes), Fresh Frozen, Irradiated; b) Cancellous Chips, Crushed 1-4mm/15 & 30cc, Freeze Dried, Irradiated c) Cancellous Chips 4-10mm/15cc, 30cc & 60cc, Freeze Dried, Irradiated d) Cancellous, Cortical Chips 1-4mm/30cc, Freeze Dried, Irradiated e) Cancellous Cubes 5-5mm/30cc, Freeze Dried, Irradiated f) Cloward Dowel (various sizes), Freeze Dried, Irradiated g) Cortical Plate 2x20cm, Freeze Dried, Irradiated h) Cortical Button 12x9mm, Freeze Dried, Irradiated i) Fascia Lata (various sizes), Freeze Dried, Irradiated j) Femoral Head w/Neck (various sizes), Fresh Frozen, Irradiated k) Femoral Ring 30mm, Fresh Frozen, Irradiated l) Femur Segment 6.0cm, Fresh Frozen, Irradiated m) Femur Shaft, Split 23cm, Fresh Frozen, Irradiated n) Fibula Ring 0.7cm, Freeze Dried, Irradiated o) Fibula Segment (various sizes), Freeze Dried, Irradiated p) Gracilis 0.7x28cm, Fresh Frozen, Irradiated q) Ilium Tricortical Block (various sizes), Freeze Dried, Irradiated r) Patella Tendon, Bisected (various sizes), Fresh Frozen, Irradiated s) Patella Tricortical 8x26mm, Freeze Dried, Irradiated t) Semitendonosus (various sizes), Fresh Frozen, Irradiated u) Tibialis Tendon Anterior (various sizes), Fresh Frozen, Irradiated v) Tibialis Tendon Posterior (various sizes), Fresh Frozen, Irradiated w) Tibial Shaft, Split (various sizes) RECALL NUMBER #B-0421-7 CODE a) 05-0131-071, 05-0131-072, 05-0138-008, 06-0007-009, 06-0007-010, 06-0019-003; b) 05-0129-001, 05-0129-002, 05-0129-004, 05-0129-005, 05-0129-007, 05-0129-008, 05-0131-040, 05-0131-041, 05-0131-042, 05-0131-043, 05-0131-044, 05-0131-045, 05-0131-046, 05-0131-047, 05-0131-048, 05-0131-049, 05-0138-023, 05-0138-024, 05-0138-025, 05-0138-026, 05-0139-014, 05-0139-016, 05-0139-017, 05-0139-018, 06-0007-015, 06-0007-016, 06-0007-017, 06-0007-018, 06-0019-017, 06-0019-018, 06-0019-020; c) 05-0129-009, 05-0129-010, 05-0129-011, 05-0129-012, 05-0129-013, 05-0129-014, 05-129-015, 05-0129-016, 05-0129-017, 05-0131-019, 05-0131-020, 05-0131-021, 05-0131-022, 05-0131-023, 05-0131-024, 05-0131-025, 05-0131-026, 05-0131-027, 05-0131-028, 05-0131-029, 05-0131-030, 05-0131-031, 05-0138-027, 05-0138-029, 05-0138-030, 05-0138-032, 05-0139-019, 05-0139-020, 05-0139-021, 05-0139-022, 05-0139-023, 06-0007-019, 06-0007-020, 06-0007-021, 06-0007-022, 06-0007-023, 06-0007-024, 06-0019-022, 06-0019-023, 06-0019-024, 06-0019-025, 06-0019-026, 06-0019-027; d) 05-0139-059, 05-0139-060, 05-0139-061, 05-0139-062, 05-0139-063, 05-0139-064, 05-0139-065, 05-0139-066, 05-0139-067, 05-0139-068; e) 05-0131-014, 05-0131-015, 05-0131-016, 05-0131-017, 05-0131-018, 06-0007-025; f) 05-0131-050, 05-0131-051, 05-0131-052, 05-0131-053, 05-0131-055, 05-0131-056, 05-0131-057, 06-0007-030; g) 05-0138-011, 05-0138-012, 05-0138-013, 05-0139-001, 05-0139-002, 06-0007-035, 06-0007-037, 06-0019-016; h) 05-0139-008; i) 06-0007-013, 06-0007-014; j) 05-0138-022, 05-0139-030, 05-0139-031, 06-0007-032, 06-0007-033; k) 06-0019-009, 06-0019-010, 06-0019-011, 06-0019-012, 06-0019-013, 06-0019-014, 6-0019-015; l) 05-0131-066, 05-0131-067, 05-0131-069, 05-0131-070; m) 05-0129-025; n) 05-0131-037, 06-0007-027, 06-0007-028; o) 05-0131-036, 05-0138-018, 05-0138-020, 05-0138-021; p) 06-0007-008; q) 05-0131-032, 05-0131-033, 05-0131-034, 05-0131-075; r) 05-0129-032, 05-0129-033, 05-0129-034, 05-0131-073, 05-0131-074, 06-0007-011, 06-0007-012; s) 06-0007-031; t) 05-0138-003, 06-0007-006; u) 06-0007-001, 06-0007-002; v) 06-0007-003, 06-0007-004; w) 05-0139-003, 05-0139-005, 05-0139-006 MANUFACTURED & RECALLED BY Alamo Tissue Services, Ltd., San Antonio, TX QUANTITY 161 units DISTRIBUTION Nationwide REASON Human Tissues, recovered from donors without adequate donor eligibility determinations, were distributed. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT A. Human Tissue for Transplantation: a) Achilles Tendon Frozen b) Patellar Ligament Hemi, Frozen c) Cartilage in Saline Vacuum d) Tibialis Anterior Tendon, Frozen e) Tibialis Tendon Frozen f) Tibialis Tendon Posterior Frozen RECALL NUMBER # B-0114-7 PRODUCT B. Human Tissue for Transplantation: a) Fascia Lyo 101-150 sq cm b) Pericardium Lyo 26-50 sq cm; c) Semitendonosus / Gracilis Frozen d) Patella Ligament Whole Frozen RECALL NUMBER # B-0115-7 CODE A.Above a) 03-0178792, 03-0173682, 03-0168103, 03-0168104, 03-0162640, 03-0168841, 03-0181591, 03-0168302, 03-0179205, 03-0181592, 03-0042572, 03-0155372, 03-0182234, 03-0032401, 03-0174931, 03-0155371, 03-0161144, 03-0182782, 03-0182623, 03-0181628, 03-0182051, 03-0032400, 03-0168301, 03-0147962, 03-0173822, 03-0182235, 03-0181627, 03-0128130, 03-0162639, 03-0182783, 03-0182624, 03-0161143, 03-0182052, 03-0151503, 03-0147961, 03-0042571, 03-0179206, 03-0172621, 03-0135831, 03-0174932, 03-0173821, 03-0173681, 03-0172251, 03-0178791, 03-0173841, 03-0173842; b) 03-0168842, 03-0181593, 03-0135832, 03-0181595, 03-0182781, 03-0178796, 03-0182625, 03-0182626, 03-0168844, 03-0173823, 03-0173825, 03-0179203, 03-0173826, 03-0182011, 03-0182049, 03-0179202, 03-0042574, 03-0139081, 03-0151502, 03-0147967, 03-0168102, 03-0162641, 03-0161142, 03-0128132, 03-0042575, 03-0168101, 03-0172618, 03-0181594, 03-0162643, 03-0168843, 03-0181438, 03-0172252, 03-0181596, 03-0178793, 03-0178794, 03-0032405, 03-0139084, 03-0179204, 03-0182047, 03-0181212, 03-0172620, 03-0182048, 03-0172617, 03-0172619, 03-0042573, 03-0042576, 03-0178795, 03-0139082, 03-0162644, 03-0173824, 03-0181213, 03-0172253, 03-0182050, 03-0151501, 03-0179201, 03-0181436, 03-0181437, 03-0032402, 03-00324404, 03-0162642, 03-0128131, 03-0128133, 03-0147968, 03-0181211; c) 03-0014874, 03-0014871, 03-0014878, 03-0014875, 03-0014876, 03-0014877; d) 03-0182053, 03-0182054, 03-0181621, 03-0179207, 03-0179208, 03-0181600, 03-0181599, 03-0168303, 03-0168304, 03-0155375, 03-0173846, 03-0173847, 03-0181622; e) 03-0042582, 03-0042580, 03-0042581, 03-0178797, 03-0178798, 03-0178799, 03-0147963, 03-0147964, 03-0147965, 03-0147966; f) 03-0155377, 03-0173845, 03-0182055, 03-0181623, 03-0155376, 03-0181598, 03-0181624, 03-0179209, 03-0181597, 03-0179210; CODE B.Above a) 03-0182237, 03-0182238, 03-0168105; b) 03-0168845, 03-0173684, 03-168846, 03-0174935, 03-0174936, 03-0173683 c) 03-0147971; d) 03-0182232, 03-0182233, 03-0155373, 03-0155374, 03-0179281, 03-0111812, 03-0174933, 03-0161141, 03-0173844, 03-0181625, 03-0173843 RECALLED BY DCI Donor Services Tissue Services Division, Nashville, TN QUANTITY 170 tissue allografts DISTRIBUTION New Mexico, TN, CA, NV, and AK REASON Human tissue, which was either implicated in a post-transplant bacterial infection, or was processed in the same manner as tissue that was implicated in a post-transplant bacterial infection, was distributed. ---------------------------------------------------------------------------