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Class 2 Device Recall |
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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
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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
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For Additional Information Contact |
Angela Tran 919-361-4008
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Manufacturer Reason for Recall |
An incorrect electrosurgical cord was included in some of the packages.
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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
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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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