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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 May 21, 2003
Date Posted January 25, 2005
Recall Status1 Terminated 3 on January 31, 2005
Recall Number Z-0418-05
Recall Event ID 30639
Product Classification Applier, Surgical, Clip - Product Code GDO
Product Weck Electrosurgical Coagulation Suction Tube (with stylet), REF 809600, Cannula 6'' ¿ 11 French, Rx Only, Sterile, Weck A Teleflex Company, Manufactured for: Weck Closure Systems, 2917 Weck Drive, Research Triangle park, NC 27709, USA.
Code Information Catalogue #809600, Lot #978933 & 978934
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		 Some stylets were not bent sufficiently during the packaging process to preclude them from sliding back into the cannula during shipment.
FDA Determined
Cause 2		 Other
Action Consignees were notified by letter sent via Federal Express on/about 05/21/2003.
Quantity in Commerce 667 units
Distribution Nationwide
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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