Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0285-2007

Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free A Port. 6 Fr...

Arrow International Inc began a recall of Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free A Port. 6 Fr. Introducer Kit. Ref Product No. AP-06014 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-0285-2007
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. 6 Fr. Introducer Kit. Ref Product No. AP-06014
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
94
Distribution
Nationwide. The firm is NOT recalling from international accounts.
Product codes and lots
Product No. AP-06014. Lot Numbers: 12130, 12134, MF3074955, MF3075069, MF3116186,MF3116232, MF3126390, MF4020623, MF4073774, MF4094578, MF4094703, MF4126653, MF5049105,MF5050037, MF5092675, MF5103680, MF6014995, MF6079156, MF6089978.