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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/
1 Weck Dr.
Research Triangle Park NC 27709
For Additional Information Contact Angela Tran
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
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.