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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-1138-04
Recall Event ID 29579
510(K)Number K920340  
Product Classification Drape, Surgical - Product Code KKX
Product Staple Removal Set/Kit; a sterile Rx convenience kit containing a staple remover and a gauze sponge. Theses kits were marketed under the following labels, 50 kits per case:
a) Medikmark inc. Staple Removal Set, reorder no. SR-2005, 3600 Bur Wood Drive, Waukegan, IL 60085;
b) Maxxim Medical Staple Removal Kit, reorder no. SD-2005, Distributed by Maxxim Medical, Oldsmar, FL 34677.
Code Information reoder no. SR-2005: lots 308045, 309064, 310137, 406019;  reorder no. SD-2005: lots 201107, 203003, 204020, 205035, 205172, 207044, 207101, 208125, 210016, 211007, 301006, 302090, 304070, 305043, 306201, 307075, 308071, 309034, 310124, 312017, 401065, 404004
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 724,800 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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