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U.S. Department of Health and Human Services

Class 2 Device Recall Medikmark and Maxxim

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  Class 2 Device Recall Medikmark and Maxxim 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-1136-04
Recall Event ID 29579
510(K)Number K920340  
Product Classification Drape, Surgical - Product Code KKX
Product Staple Removal Tray/Set/Kit; a sterile Rx convenience kit containing a staple remover instrument, an alcohol prep pad, a PVP prep pad and a gauze sponge. Theses kits were marketed under the following labels, 50 kits per case:
a) Medikmark inc. Staple Removal Tray, reorder no. RS-2000, 3600 Bur Wood Drive, Waukegan, IL 60085;
b)Medikmark Inc. Staple Removal Set, reorder no. SR-2000; 3600 Bur Wood Drive, Waukegan, IL 60085;
c) Maxxim Medical Staple Removal Kit, reorder no. SD-2000, Distributed by Maxxim Medical, Oldsmar, FL 34677.
Code Information reorder no. RS-2000: lot 304075; reorder no. SR-2000: lots 201106, 205173, 209014, 210017, 211084, 301059, 303069, 305096, 305143, 308044, 310136, 311136, 312059, 401132, 404160, 405062, 406018; reorder no. SD-2000: lot 204019
Recalling Firm/
Medikmark, Incorporated
3600 Burwood Dr
Waukegan IL 60085-8399
For Additional Information Contact Ms. Rita Taylor
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
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 9,100 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.