Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0277-2007

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. 10 Fr. Introducer Kit. Ref Product No. AP-06042 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-0277-2007
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. 10 Fr. Introducer Kit. Ref Product No. AP-06042.
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
251
Distribution
Nationwide. The firm is NOT recalling from international accounts.
Product codes and lots
Product No. AP-06042. Lot Numbers: 11916, MF2092169, MF2092256, MF3013079, MF3013159, MF3013315, MF3013320, MF3023358, MF3033614, MF3043940, MF3064659, MF3054234, MF3075086, MF3075140, MF3116147, MF3126395, MF4016579, MF4031049, MF4031484, MF4063059, MF4063266, MF4105260, MF4105483, MF4115980, MF4126889, MF4126890, MF5027945, MF5059894, MF5060175, MF5092679, MF5103210, MF5113791, MF5124527, MF6015496, MF6025735, MF6026194, MF6057764, MF6080022, MR3110192, MR3110194, MS2100122, MS4041843, MS4041844, MS4041845.