Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0284-2007

Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-free A Port. 10 Fr...

Arrow International Inc began a recall of Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-free A Port. 10 Fr. Introducer Kit. Ref. Product No. AP-06015 on . The reason FDA records is "Catheter has separated from the infusion port body". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0284-2007
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Arrow International LLC (subsidiary of Teleflex Incorporated)
Product
Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-free A Port. 10 Fr. Introducer Kit. Ref. Product No. AP-06015
Product code
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Reason for recall
Catheter has separated from the infusion port body.
FDA root cause
Other
Action
The recall notification was sent out to their US customers on 9/29/2006.
Quantity in commerce
890
Distribution
Nationwide. The firm is NOT recalling from international accounts.
Product codes and lots
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.