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Terminated

Ref. No. 121505 Atrauclip, 15 Large Titanium Clips/Cartridge and Ref. No. 121506 Atrauclip, 10 Large Titanium Clips/Cartridge

FDA Recall Z-1386-04 · Posted 2004-08-24

Recalling FirmWeck
Recall StatusTerminated
Product CodeHBT
Date Initiated2003-10-24
Date Terminated2004-08-25
Product Quantity91,869 units for all products under recall

Reason for Recall

Hole in the sterile unit blister pack that could compromise sterility.

Firm Action

The consignees were notified of the recall via letter beginning October 24, 2003 asking for return of the product.

Root Cause

Other

Distribution Pattern

Nationwide and to accounts in Canada, Europe Asia, and South/Latin America

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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