Implantable Vascular Access system --Infusion Ports with Silicone Rubber Catheter. Latex-free A Port. 9 Fr. Introducer Kit. Ref. Product No. AP-06018.
This recall has been terminated (originally issued December 19, 2006).
- Company
- Arrow International Inc
- Recall Initiated
- September 29, 2006
- Posted
- December 19, 2006
- Terminated
- June 4, 2007
- Recall Number
- Z-0282-2007
- Quantity
- 452
- Firm Location
- Reading, PA
- Official Source
- View on FDA website ↗
Reason for Recall
Catheter has separated from the infusion port body.
Distribution
Nationwide. The firm is NOT recalling from international accounts.
Lot / Code Info
Product No. AP-06018. Lot Numbers: MF2071557, MF2081915, MF2112752, MF3013138, MF3013309, MF3043927, MF3054236, MF3054472, MF3054594, MF3074941, MF3075061, MF3085480, MF3095763, MF3116074, MF3116187, MF4016702, MF4016725, MF4020805, MF4031013, MF4031188, MF4031373, MF4052203, MF4063052, MF4073779, MF4073837, MF4094885, MF4105259, MF4105799, MF4126881, MF5017404, MF5028031, MF5038301, MF5038425, MF5038760, MF5049322, MF5059729, MF5059889, MF5060171, MF5081718, MF5103002, MF5103502, MF5113789, MF5113991, MF6014861, MF6014998, MF6036561, MF6036618, MF6058293, MF6058347, MF6068925.
Root Cause
Other
Action Taken
The recall notification was sent out to their US customers on 9/29/2006.