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U.S. Department of Health and Human Services

Class 2 Device Recall MediChoice

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  Class 2 Device Recall MediChoice see related information
Date Initiated by Firm July 12, 2004
Date Posted July 22, 2004
Recall Status1 Terminated 3 on June 27, 2006
Recall Number Z-1137-04
Recall Event ID 29579
510(K)Number K920340  
Product Classification Drape, Surgical - Product Code KKX
Product MediChoice Skin Staple Remover, reorder no. SSR 1001; a sterile Rx convenience kit containing a skin staple remover, a PVP prep pad and a 3 x 3 gauze sponge; 50 kits per case; Made for Owens & Minor
Code Information reorder no. SSR 1001: lots 305097, 306073, 306212, 312109, 401003, 101133, 403154, 404040, 405003, 406021
Recalling Firm/
Manufacturer
Medikmark, Incorporated
3600 Burwood Dr
Waukegan IL 60085-8399
For Additional Information Contact Ms. Rita Taylor
847-596-7723
Manufacturer Reason
for Recall
The tip of the staple remover may puncture a hole in the wall of the tray, compromising the sterility of the kit.
FDA Determined
Cause 2
Other
Action Recall notifications were sent by fax and follow-up registered mail to the direct account distributors and users on 7/12-15/04. The accounts were informed of the potential non-sterility of the product and were instructed to immediately discontinue sale/use of the products and place all inventory in quarantine pending return to Medikmark. Distributors were instructed to sub-recall the kits from their customers. Any questions were directed to 1-847-596-7723.
Quantity in Commerce 70,750 kits
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.
510(K) Database 510(K)s with Product Code = KKX and Original Applicant = MEDIKMARK, INC.
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