Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0273-2007

Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free A(2) Port, 10...

Arrow International Inc began a recall of Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free A(2) Port, 10 Fr. Introducer Kit Ref Product No. AP-06530 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-0273-2007
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(2) Port, 10 Fr. Introducer Kit Ref Product No. AP-06530
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
210
Distribution
Nationwide. The firm is NOT recalling from international accounts.
Product codes and lots
Product No: AP-06530. Lot Numbers: 11750, 11999, 12059, MF4031397, MF4042081, MF4062934, MF4063103, MF4073794, MF5027702, MF5059738, MF5060177, MF5060656, MF5081903, MF5103211, MF6036473, MF6036909, MF6068938, MS3100148.