Ref. No. 121505 Atrauclip, 15 Large Titanium Clips/Cartridge and Ref. No. 121506 Atrauclip, 10 Large Titanium Clips/Cart
FDA device recall Z-1386-04 · posted 2004-08-24 · Terminated
Recall details
- Recalling firm
- Weck
- Reason for recall
- Hole in the sterile unit blister pack that could compromise sterility.
- Action taken
- The consignees were notified of the recall via letter beginning October 24, 2003 asking for return of the product.
- Root cause
- Other
- Status
- Terminated
- Product code
- HBT
- Quantity affected
- 91,869 units for all products under recall
- Distribution
- Nationwide and to accounts in Canada, Europe Asia, and South/Latin America
- Date initiated
- 2003-10-24
- Date posted
- 2004-08-24
- Date terminated
- 2004-08-25
- Location
- Research Triangle Park, NC
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