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U.S. Department of Health and Human Services

Class 3 Device Recall

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  Class 3 Device Recall see related information
Date Initiated by Firm October 31, 2001
Date Posted January 13, 2005
Recall Status1 Terminated 3 on January 31, 2005
Recall Number Z-0393-05
Recall Event ID 30640
Product Classification Applier, Surgical, Clip - Product Code GDO
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.
Code Information Catalog #544965, Lot #694505 & 694506
Recalling Firm/
1 Weck Dr.
Research Triangle Park NC 27709
For Additional Information Contact Angela Tran
Manufacturer Reason
for Recall
The flush port on some appliers was occluded with an epoxy resin during manufacturing.
FDA Determined
Cause 2
Action Consignees were notified by letter on 10/31/2001.
Quantity in Commerce 66 units
Distribution AL, AZ, CA,CO, CT, FL,GA, KS, NC, NH, NJ, NY, TN, TX, VA,WA.Australia, Singapore, Venezuela.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.