Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0276-2007

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

Arrow International Inc began a recall of Implantable Vascular Access system -- Infusion Ports with Silicone Rubber Catheter. Latex-Free Low Profile B Port, 6 Fr. Introducer Kit. Ref Product No... 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-0276-2007
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 B Port, 6 Fr. Introducer Kit. Ref Product No. AP-06046
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
42
Distribution
Nationwide. The firm is NOT recalling from international accounts.
Product codes and lots
Product No. AP-06046. Lot Number: MF2102346, MF2112623, MF2122946, MF3023531, MF3043934, MF3074943, MF3085287, MF3095692, MF4020550, MF4031019, MF4031353, MF4041638, MF4063174, MF4105485, MF5017413, MF5017546, MF5038769.