FDA Medical Device Recalls (openFDA)
Medikmark, Incorporated: 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
- Recall number
- Z-1137-04
- Recalling firm
- Medikmark, Incorporated
- 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
- Status
- Terminated
- Initiated
- 2004-07-12
- Posted
- 2004-07-22
- Terminated
- 2006-06-27
- Reason
- The tip of the staple remover may puncture a hole in the wall of the tray, compromising the sterility of the kit.
- Root cause
- 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
- 70,750 kits
- Distribution
- Nationwide
- Lot, serial or model codes
- reorder no. SSR 1001: lots 305097, 306073, 306212, 312109, 401003, 101133, 403154, 404040, 405003, 406021
- 510(k) numbers
- ["K920340"]
- PMA numbers
- not on file
- Product code
- KKX
- Firm FEI
- 1450943
- Firm city
- Waukegan
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28