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.
FDA Recall Z-1136-04 · Posted 2004-07-22
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Recalling FirmMedikmark, Incorporated
Recall StatusTerminated
Product CodeKKX
Date Initiated2004-07-12
Date Terminated2006-06-27
Product Quantity9,100 kits
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.
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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