Catalog/Lot numbers, respectively:   331411/60463283; 331412/60463404; 331417/60440555; 331542/60437004; 331545/60460702; 331565/60468520; 331565/60481188; 331567/60451432; 331567/60481276; 331582/60433989; 331583/60437935; 331585/60454731; 331585/60477325; 331587/60440553; 331592/60454732; 331595/60460707; 331712/60460705; 331812/60444733; 331918/60454742; 331935/60430137; 58003/60447789 ; 580099/60452854; 580125/60480896; 58017660456867 ; 580179/60453991; 580187/60444305; 7B3013/60459863; 7B3040/60451968;   S1200600N/60425597; S1200600N/60451313 S1200600N/60435666; S1200600N/60451450

General Hospital and Personal Use Devices

2

Yes

The units were sent to medical facilities in the following states, as listed: CA, CO, DC, FL, GA, IL, LA, MA, MI, MD, MN, MO, MS, NC, NJ, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WI, WV The product was also distributed to the following foreign accounts located in Germany, Japan, Puerto Rico, and South America.

18G Catheter is a component in various kits.

Reference No. 384134, Lot No. 2326770.

General Hospital and Personal Use Devices

2

Yes

Nationwide

BD First PICC 3F 65 cm Single Lumen Procedure Kit.

All lots numbers included

General Hospital and Personal Use Devices

3

Yes

International Distribution --- country of Belgium.

Medtronic 8578 Sutureless Pump Connector Revision Kit || Medtronic Inc., Minneapolis, MN 55432 || A part of the SynchroMed II Infusion system, which is designed to restore and provide intrathecal administration of drug therapy.

All lots numbers included

General Hospital and Personal Use Devices

3

Yes

International Distribution --- country of Belgium.

Model 8596SC Intrathecal Catheter Pump Segment Revision Kit || Medtronic Inc., Minneapolis, MN 55432 || A part of the SynchroMed II Infusion system, which is designed to restore and provide intrathecal administration of drug therapy.

All lots numbers included

General Hospital and Personal Use Devices

3

Yes

International Distribution --- country of Belgium.

Model 8709SC Indura 1P || One-Piece Intrathecal Catheter || Medtronic Inc., Minneapolis, MN 55432 || A part of the SynchroMed II Infusion system, which is designed to restore and provide intrathecal administration of drug therapy.

All lots numbers included

General Hospital and Personal Use Devices

3

Yes

International Distribution --- country of Belgium.

Model 8731SC Intrathecal Catheter || Medtronic Inc., Minneapolis, MN 55432 || A part of the SynchroMed II Infusion system, which is designed to restore and provide intrathecal administration of drug therapy.

Lot #MDPZ600 Expiration date 2015/02

General Hospital and Personal Use Devices

2

Yes

Worldwide Distribution - - USA, including the states of CA, NJ, AZ, PA, TN and the country of Spain.

8F Plastic Dignity Mid-Sized CT Port w/Silicone Filled Suture Holes and w/Attachable ChronoFlex Polyurethane Catheter. Catalog # MRCTI8000S. The Power Injectable, Implantable Infusion Port is an implantable single fluid reservoir port with a polyurethane (8F) catheter attachable for application by the inserting physician.

Product No. AP-06528. Lot Number: 12054, MF3033635, MF3075166, MF3095536, MF3105900, MF3116038, MF4016607, MF4020455, MF4020838, MF4063175, MF4073793, MF4084293, MF4084406, MF4105408, MF5017415, MF5049326, MF6014778, MF6068936, MF6079334.

General Hospital and Personal Use Devices

2

Yes

Nationwide. The firm is NOT recalling from international accounts.

Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. || Latex-Free A(2) Port , 12 Fr. Introducer Kit. || Ref Product Code: AP-06528

Product No. AP-06520. 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.

General Hospital and Personal Use Devices

2

Yes

Nationwide. The firm is NOT recalling from international accounts.

Implantable Vascular Access system -- Infusion Ports with Silicone Rubber Catheter. || Latex-Free A Port, 10 Fr. Introducer Kit. || Ref Product No. AP-06520

Product No. AP-06046. Lot Number: MF2102346, MF2112623, MF2122946, MF3023531, MF3043934, MF3074943, MF3085287, MF3095692, MF4020550, MF4031019, MF4031353, MF4041638, MF4063174, MF4105485, MF5017413, MF5017546, MF5038769.

General Hospital and Personal Use Devices

2

Yes

Nationwide. The firm is NOT recalling from international accounts.

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

Product No. AP-06042. 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.

General Hospital and Personal Use Devices

2

Yes

Nationwide. The firm is NOT recalling from international accounts.

Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. || Latex-Free Low Profile Port. 10 Fr. Introducer Kit. || Ref Product No. AP-06042.

Product No. AP-06040. 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.

General Hospital and Personal Use Devices

2

Yes

Nationwide. The firm is NOT recalling from international accounts.

Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. || Latex-Free Low Profile Port. 9 Fr. Introducer Kit. || Ref Product No. AP -06040

Product No. AP-06036. 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.

General Hospital and Personal Use Devices

2

Yes

Nationwide. The firm is NOT recalling from international accounts.

Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. || Latex-Free Low Profile Port. 6 Fr. Introducer Kit || Ref. Product No. AP-06036

Product No. AP-06022. 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.

General Hospital and Personal Use Devices

2

Yes

Nationwide. The firm is NOT recalling from international accounts.

Implantable Vascular Access system -- Infusion Ports with Silicone Rubber Catheter. || Latex-Free Low Profile Port. 10 Fr. Introducer Kit || Ref Product No. AP-06022

Product No. AP-06020. 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.

General Hospital and Personal Use Devices

2

Yes

Nationwide. The firm is NOT recalling from international accounts.

Implantable Vascular Access system -- Infusion Ports with Silicone Rubber Catheter. || Latex-Free Low Profile Port. 9 Fr. Introducer Kit || Ref Product No. AP-06020

Product No. AP-06018. 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.

General Hospital and Personal Use Devices

2

Yes

Nationwide. The firm is NOT recalling from international accounts.

Implantable Vascular Access system --Infusion Ports with Silicone Rubber Catheter. || Latex-free A Port. 9 Fr. Introducer Kit. || Ref. Product No. AP-06018.

Product No. AP-06016. Lot Numbers: MF2092160, MF2092258, MF4031012, MF4041798, MF4063372, MF4073836, MF4105283, MF6015284, MF6026177.

General Hospital and Personal Use Devices

2

Yes

Nationwide. The firm is NOT recalling from international accounts.

Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. || Latex-Free Low Profile Port. 6 Fr. Introducer Kit. || Ref. Product No. AP-06016.

Product No. AP-06015. 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.

General Hospital and Personal Use Devices

2

Yes

Nationwide. The firm is NOT recalling from international accounts.

Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. || Latex-free A Port. 10 Fr. Introducer Kit. || Ref. Product No. AP-06015

Product No. AP-06014. Lot Numbers: 12130, 12134, MF3074955, MF3075069, MF3116186,MF3116232, MF3126390, MF4020623, MF4073774, MF4094578, MF4094703, MF4126653, MF5049105,MF5050037, MF5092675, MF5103680, MF6014995, MF6079156, MF6089978.

General Hospital and Personal Use Devices

2

Yes

Nationwide. The firm is NOT recalling from international accounts.

Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. || Latex-Free A Port. 6 Fr. Introducer Kit. || Ref Product No. AP-06014

Product No. AP-06013. 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.

General Hospital and Personal Use Devices

2

Yes

Nationwide. The firm is NOT recalling from international accounts.

Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. || Latex-Free A Port. 9 Fr. Introducer Kit || Ref Product No. AP-06013.

Product No. AP-01510. 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.

General Hospital and Personal Use Devices

2

Yes

Nationwide. The firm is NOT recalling from international accounts.

Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. || Latex-Free A Port. || Ref Product No. AP-01510

Product No: AP-06530. Lot Numbers: 11750, 11999, 12059, MF4031397, MF4042081, MF4062934, MF4063103, MF4073794, MF5027702, MF5059738, MF5060177, MF5060656, MF5081903, MF5103211, MF6036473, MF6036909, MF6068938, MS3100148.

General Hospital and Personal Use Devices

2

Yes

Nationwide. The firm is NOT recalling from international accounts.

Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. || Latex-Free A(2) Port, 10 Fr. Introducer Kit || Ref Product No. AP-06530

Product No. AP-06535. Lot Numbers: MF3023376, MF3044179, MF3085273, MF3126313, MF4020636, MF6014780, MF6025930, MF6079639, MR2070141.

General Hospital and Personal Use Devices

2

Yes

Nationwide. The firm is NOT recalling from international accounts.

Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. || Latex-Free A(2) Port, 17 Fr. Introducer Kit || REF Product No. AP-06535

Product No. AP-01013. Lot Numbers: 11284, MF3085483, MF4031500, MF4063259.

General Hospital and Personal Use Devices

2

Yes

Nationwide. The firm is NOT recalling from international accounts.

Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. || Ref Product No. AP-01013 || Latex-Free Low Profile Port

Product code AP-01007: MF2041118, MF2112625, MF3013201, MF3105944, MF4031465.

General Hospital and Personal Use Devices

2

Yes

Nationwide. The firm is NOT recalling from international accounts.

Implantable Vascular Access System -- Infusion Ports with Silicone Rubber catheter. || Latex Free A Port || Ref Product No. AP-01007.