Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0279-2007

Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free Low Profile...

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.