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U.S. Department of Health and Human Services

Class 3 Device Recall

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 Class 3 Device Recallsee related information
Date Initiated by FirmAugust 18, 2004
Date PostedOctober 22, 2004
Recall Status1 Terminated 3 on January 31, 2005
Recall NumberZ-0031-05
Recall Event ID 30060
Product Classification Applier, Hemostatic Clip - Product Code HBT
ProductHem-o-lok Endo5 Ligation Applier
Code Information Catalog number 544965, Lot 943704, 943705, 954592
Recalling Firm/
Manufacturer		 Weck
1 Weck Dr.
Research Triangle Park NC 27709
Manufacturer Reason
for Recall		The jaws may break during clip loading or clip application.
FDA Determined
Cause 2		Other
ActionConsignees were notified via Federal Express (Domestic) and by email (International and Weck Sales Representatives).
Quantity in Commerce119 units
DistributionNationwide; Australia, Buenos Aires, Canada, France, Korea, New Zealand, Singapore.
Total Product Life CycleTPLC 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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