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Terminated

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

FDA Recall Z-1137-04 · Posted 2004-07-22

Recalling FirmMedikmark, Incorporated
Recall StatusTerminated
Product CodeKKX
Date Initiated2004-07-12
Date Terminated2006-06-27
Product Quantity70,750 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.

K920340SUTURE REMOVAL KITMedikmark, Inc. · 1992-04-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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