FDA Medical Device Recalls (openFDA)
Weck: Ref. No. 523771 - Hemoclip, 15 Large Titanium Clips/Cartridge (Non-Sterile) and Ref. No. 523871- Hemoclip, 10 Large Titanium Clips/Cartridge (Non-Steile)
- Recall number
- Z-1389-04
- Recalling firm
- Weck
- Product
- Ref. No. 523771 - Hemoclip, 15 Large Titanium Clips/Cartridge (Non-Sterile) and Ref. No. 523871- Hemoclip, 10 Large Titanium Clips/Cartridge (Non-Steile)
- Status
- Terminated
- Initiated
- 2003-10-24
- Posted
- 2004-08-24
- Terminated
- 2004-08-25
- Reason
- Hole in the sterile unit blister pack that could compromise sterility.
- Root cause
- Other
- Action
- The consignees were notified of the recall via letter beginning October 24, 2003 asking for return of the product.
- Quantity
- 91,869 units for all products under recall
- Distribution
- Nationwide and to accounts in Canada, Europe Asia, and South/Latin America
- Lot, serial or model codes
- All lots manufactured between 2001-8 throught 2002-12 for the 15 and 10 Large Titanium Clips and lots 880608 and 944135 for the 10 Large Titanium Clips
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HBT
- Firm FEI
- 3005747797
- Firm city
- Research Triangle Park
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28