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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm January 25, 2001
Date Posted December 21, 2004
Recall Status1 Terminated 3 on December 21, 2004
Recall Number Z-0340-05
Recall Event ID 30641
Product Classification Cord, Electric, For Endoscope - Product Code FFZ
Product Weck, Bipolar Forceps Cord, REF 394236, 1 (One) Cord, Length 12 Feet (3.7m), Sterile, Single Use, Disposable, Weck Closure Systems¿, Distributed by : Weck Closure Systems, One Weck Dr. Research Triangle Park, NC 27709, USA
Code Information Catalog #394236, Lot 3504519
Recalling Firm/
1 Weck Dr.
Research Triangle Park NC 27709
For Additional Information Contact Angela Tran
Manufacturer Reason
for Recall
An incorrect electrosurgical cord was included in some of the packages.
FDA Determined
Cause 2
Mixed-up of materials/components
Action Consignees were notified by letter sent Federal Express on 01/25/2001.
Quantity in Commerce 462 units
Distribution Nationwide, Singapore
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.