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U.S. Department of Health and Human Services

Class 2 Device Recall Weck Hemoclip Plus Ligating Clips

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  Class 2 Device Recall Weck Hemoclip Plus Ligating Clips see related information
Date Initiated by Firm October 24, 2003
Date Posted August 24, 2004
Recall Status1 Terminated 3 on August 25, 2004
Recall Number Z-1392-04
Recall Event ID 29820
Product Classification Applier, Hemostatic Clip - Product Code HBT
Product Ref. No. 533735 and 534735 Hemoclip Plus, 25 Small Titanium Clips, Cartridge; Ref. No. 533870 Hemoclip Plus, 10 Large Titanium Clips/Cartridge and Ref. No. 533700 Hemoclip Plus, 25 Medium Titanium Clips/Cartridge
Code Information All lots manufactured between 2001-8 through 2002-12 for all three products and lots 738967, 763871 and 714124 for 25 Small Titanium Clips; lots 703251, 722666 and 825952 for 10 Large Titanium Clips and lots 738966, 754641 and 824238 for 25 Medium Titanium Clips
Recalling Firm/
Manufacturer		 Weck
1 Weck Dr.
Research Triangle Park NC 27709
For Additional Information Contact Angela Tran
919-544-8000
Manufacturer Reason
for Recall		 Hole in the sterile unit blister pack that could compromise sterility.
FDA Determined
Cause 2		 Other
Action The consignees were notified of the recall via letter beginning October 24, 2003 asking for return of the product.
Quantity in Commerce 91,869 units for all products under recall
Distribution Nationwide and to accounts in Canada, Europe Asia, and South/Latin America
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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