FDA Medical Device Recalls (openFDA)
Weck: Weck, Endo5, Hem-o-lok ML, Ref 544965, Hem-o-lok ML Endoscopic Clip Applier, Non-Sterile Clean and sterilize before use. Weck Closure Systems, TFX Medical Ltd., Halifax Road, P.O. Box 138, High Wycombe HP123NB U.K.
- Recall number
- Z-0393-05
- Recalling firm
- Weck
- Product
- Weck, Endo5, Hem-o-lok ML, Ref 544965, Hem-o-lok ML Endoscopic Clip Applier, Non-Sterile Clean and sterilize before use. Weck Closure Systems, TFX Medical Ltd., Halifax Road, P.O. Box 138, High Wycombe HP123NB U.K.
- Status
- Terminated
- Initiated
- 2001-10-31
- Posted
- 2005-01-13
- Terminated
- 2005-01-31
- Reason
- The flush port on some appliers was occluded with an epoxy resin during manufacturing.
- Root cause
- Other
- Action
- Consignees were notified by letter on 10/31/2001.
- Quantity
- 66 units
- Distribution
- AL, AZ, CA,CO, CT, FL,GA, KS, NC, NH, NJ, NY, TN, TX, VA,WA.Australia, Singapore, Venezuela.
- Lot, serial or model codes
- Catalog #544965, Lot #694505 & 694506
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GDO
- 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
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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