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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/
Manufacturer		 Weck
1 Weck Dr.
Research Triangle Park NC 27709
For Additional Information Contact Angela Tran
919-361-4008
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.
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