FDA Medical Device Recalls (openFDA)
Medikmark, Incorporated: 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.
- Recall number
- Z-1136-04
- Recalling firm
- Medikmark, Incorporated
- 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.
- 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
- 9,100 kits
- Distribution
- Nationwide
- Lot, serial or model codes
- 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
- 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
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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