Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free A Port. 9 Fr. Introducer Kit Ref Product No. AP-06013.
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-0286-2007
- Quantity
- 331
- 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-06013. Lot Numbers: MF2102345, MF2112624, MF2122835, MF3013200, MF3023408, MF3023552, MF3033766, MF3054406, MF3074987, MF3075143, MF3095708, MF3105784, MF3116130, MF3116231, MF4016530, MF4020444, MF4020470, MF4041797, MF4062926, MF4073773, MF4084282, MF4094881, MF4116112, MF4126522, MF4126770, MF4126879, MF5017542, MF5028152, MF5038758, MF5049103, MF5059726, MF5060460, MF5081715, MF5082408, MF5092546, MF5103679, MF5113983, MF6014772, MF6026163, MF6036927.
Root Cause
Other
Action Taken
The recall notification was sent out to their US customers on 9/29/2006.