Implantable Vascular Access system -- Infusion Ports with Silicone Rubber Catheter. Latex-Free Low Profile Port. 9 Fr. Introducer Kit Ref Product No. AP-06020
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-0281-2007
- Quantity
- 514
- 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-06020. Lot Numbers: MF1075363, MF2071759, MF2071795, MF2081849, MF2081900, MF2122871, MF2122962, MF3013303, MF3023498, MF3033750, MF3054449, MF3054482, MF3085186, MF3085246, MF3085395, MF3095548, MF3116233, MF3116244, MF4020723, MF4020901, MF4031014, MF4031015, MF4031466, MF4052331, MF4062929, MF4063264, MF4084283, MF4094580, MF4094705, MF4105328, MF4105577, MF4115963, MF4126528, MF4126656, MF4126883, MF4126884, MF5017406, MF5027697, MF5028032, MF5028154, MF5038599, MF5050172, MF5059730, MF5059892, MF5060353, MF5060465, MF5070948, MF5081719, MF5081720, MF5124397, MF5082119, MF5092548, MF5103503, MF5103681, MF5113874, MF5124524, MF6014999, MF6047362, MF6047363, MF6047523, MF6057740, MF6057761, MF6068649, MF6068928, MF6079295, MF6079297.
Root Cause
Other
Action Taken
The recall notification was sent out to their US customers on 9/29/2006.