Z-1138-04

Staple Removal Set/Kit; a sterile Rx convenience kit containing a staple remover and a gauze sponge. Theses...

Name: Z-1138-04 Staple Removal Set/Kit; a sterile Rx convenience kit containing a staple remover and a gauze sponge. Theses...
Creator: Medikmark, Incorporated
Published: 2004-07-12
License: https://open.fda.gov/license/

Gyn-Disposables, Inc. / initiated 2004-07-12 / Terminated / root cause: packaging

FDA source

Medikmark, Incorporated began a recall of 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... on 2004-07-12. The reason FDA records is "The tip of the staple remover may puncture a hole in the wall of the tray, compromising the sterility of the kit". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1138-04
Status: Terminated
Initiated: 2004-07-12
Posted: 2004-07-22
Terminated: 2006-06-27
Recalling firm: Gyn-Disposables, Inc.
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.
Product code: KKX Drape, Surgical, Antimicrobial
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.
Root cause tag: packaging
FDA 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 in commerce: 724,800 kits
Distribution: Nationwide
Product codes and lots: 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

Product code KKX

K920340Class IISuture Removal KitMedikmark, Inc. / cleared 1992-04-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)