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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 April 01, 2005
Date Posted April 08, 2005
Recall Status1 Terminated 3 on July 08, 2005
Recall Number Z-0699-05
Recall Event ID 31553
510(K)Number K990145  
Product Classification Laparoscope, General & Plastic Surgery - Product Code GCJ
Product BCP-7A, Quick Silver Bipolar Coagulation Probe, For use w/dual Plug Bipolar Generators * Catheter Diameter: 7 FR. Catheter Length: 35 CM. Disposable ¿ Single Use Only * Sterile/EO * Rx Only * Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105.
Code Information Product Order #BCP-7A: Lot #1331630, Vendor Exp. Date 01/2005 * Label Exp. Date 02/2005
Recalling Firm/
Manufacturer		 Wilson-Cook Medical Inc
5951 Grassy Creek Blvd
Winston Salem NC 27105-1206
For Additional Information Contact Sharon Miles
800-245-4707
Manufacturer Reason
for Recall		 The expiration date listed on the product label is greater than the vendor recommended expiration date.
FDA Determined
Cause 2		 Labeling False and Misleading
Action Consignees were notified by certified mail on 04/01/2005.
Quantity in Commerce 18 units
Distribution Nationwide, Brazil, Canada, Hong Kong, Ireland & Pakistan
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.
510(K) Database 510(K)s with Product Code = GCJ and Original Applicant = WILSON-COOK MEDICAL, INC.
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