Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0272-2007

Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free A(2) Port, 17...

Arrow International Inc began a recall of Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free A(2) Port, 17 Fr. Introducer Kit REF Product No. AP-06535 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-0272-2007
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, 17 Fr. Introducer Kit REF Product No. AP-06535
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
89
Distribution
Nationwide. The firm is NOT recalling from international accounts.
Product codes and lots
Product No. AP-06535. Lot Numbers: MF3023376, MF3044179, MF3085273, MF3126313, MF4020636, MF6014780, MF6025930, MF6079639, MR2070141.