Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0278-2007

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

Arrow International Inc began a recall of Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free Low Profile Port. 9 Fr. Introducer Kit. Ref Product No. AP -06040 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-0278-2007
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 Port. 9 Fr. Introducer Kit. Ref Product No. AP -06040
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
288
Distribution
Nationwide. The firm is NOT recalling from international accounts.
Product codes and lots
Product No. AP-06040. Lot Numbers: MF2082014, MF2092092, MF2102287, MF2122972, MF3023424, MF3033561, MF3033608, MF3054587, MF3074949, MF3075147, MF3085288, MF3085340, MF3095656, MF3095740, MF3105983, MF3126394, MF4016539, MF4031048, MF4031211, MF4031352, MF4041932, MF4062931, MF4063056, MF4083962, MF4084405, MF4126532, MF5017410, MF5038601, MF5050044, MF5059734, MF5081723, MF5124399, MF6015389, MF6025738, MF6026066, MF6047369, MF6047370, MF6025851, MF6057763.