Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0287-2007

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-01510 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-0287-2007
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-01510
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
204
Distribution
Nationwide. The firm is NOT recalling from international accounts.
Product codes and lots
Product No. AP-01510. Lot Numbers: MF2061389, MF2071761, MF2082058, MF2122799,MF2122869, MF3013124, MF3023533, MF3033713, MF3044092, MF3044143, MF3054233, MF3054527,MF3064662, MF3064871, MF3085292, MF3085315, MF3095651, MF3116183, MF3116212, MF3126476, MF4016721, MF4020469, MF4020739, MF4105255, MF5017539, MF5081888, MF6068638, MS3110153,MS4041605, MS4041616, MS4041617,MS4041618.