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Terminated

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.

FDA Recall Z-0393-05 · Posted 2005-01-13

Recalling FirmWeck
Recall StatusTerminated
Product CodeGDO
Date Initiated2001-10-31
Date Terminated2005-01-31
Product Quantity66 units

Reason for Recall

The flush port on some appliers was occluded with an epoxy resin during manufacturing.

Firm Action

Consignees were notified by letter on 10/31/2001.

Root Cause

Other

Distribution Pattern

AL, AZ, CA,CO, CT, FL,GA, KS, NC, NH, NJ, NY, TN, TX, VA,WA.Australia, Singapore, Venezuela.

Official Source

View FDA Recall →

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

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