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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/
Manufacturer		 Weck
1 Weck Dr.
Research Triangle Park NC 27709
For Additional Information Contact Angela Tran
919-361-4008
Manufacturer Reason
for Recall		 The flush port on some appliers was occluded with an epoxy resin during manufacturing.
FDA Determined
Cause 2		 Other
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.
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