The affected device is labeled Angio-Seal Vascular Closure Device 6F VIP Platform, model 610130. The recalled product is
FDA device recall Z-0157-2007 · posted 2006-11-07 · Terminated
Recall details
- Recalling firm
- St. Jude Medical / Daig Division
- Reason for recall
- The Angio Seal VIP 6F devices were incorrectly packaged with a 0.038'' guidewire vs. the required 0.035'' guidewire.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- MGB
- Quantity affected
- 4,770 Units
- Distribution
- Nationwide.
- Date initiated
- 2006-06-07
- Date posted
- 2006-11-07
- Date terminated
- 2006-11-13
- Location
- Minnetonka, MN
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