Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0270-2007

Implantable Vascular Access System -- Infusion Ports with Silicone Rubber catheter. Latex Free A Port Ref...

Arrow International Inc began a recall of Implantable Vascular Access System -- Infusion Ports with Silicone Rubber catheter. Latex Free A Port Ref Product No. AP-01007 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-0270-2007
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 Ref Product No. AP-01007.
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
17
Distribution
Nationwide. The firm is NOT recalling from international accounts.
Product codes and lots
Product code AP-01007: MF2041118, MF2112625, MF3013201, MF3105944, MF4031465.