Recall Z-1138-04 ยท KKX Drape, Surgical, Antimicrobial
Medikmark, Incorporated
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.
| Date | Jul 22, 2004 (initiated Jul 12, 2004) |
| Status | Terminated |
| 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 | 724,800 kits |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K920340 | SUTURE REMOVAL KIT Medikmark, Inc., Apr 23, 1992 |