The affected device is labeled Angio-Seal Vascular Closure Device 6F VIP Platform, model 610130. The recalled product is the 6 French model size.
- Company
- St. Jude Medical Daig Division
- Recall Initiated
- June 7, 2006
- Posted
- November 7, 2006
- Terminated
- November 13, 2006
- Recall Number
- Z-0157-2007
- Quantity
- 4,770 Units
- Firm Location
- Minnetonka, MN
Reason for Recall
The Angio Seal VIP 6F devices were incorrectly packaged with a 0.038'' guidewire vs. the required 0.035'' guidewire.
Distribution
Nationwide.
Lot / Code Info
Lot 1204437
Root Cause
Other
Action Taken
All consignees were notified by letter on June 7, 2006. All product is to be retreived by recalling firm''s sales force for return to St. Jude Medical, in Minnetonka, MN.
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