Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free Low Profile Port. 10 Fr. Introducer Kit. Ref Product No. AP-06042.
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-0277-2007
- Quantity
- 251
- 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-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.
Root Cause
Other
Action Taken
The recall notification was sent out to their US customers on 9/29/2006.