Z-0279-2007
Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free Low Profile...
Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2006-09-29 / Terminated
Arrow International Inc began a recall of Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free Low Profile Port. 6 Fr. Introducer Kit Ref. Product No. AP-06036 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-0279-2007
- 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 Low Profile Port. 6 Fr. Introducer Kit Ref. Product No. AP-06036
- 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
- 125
- Distribution
- Nationwide. The firm is NOT recalling from international accounts.
- Product codes and lots
- 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.
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