| Class 2 Device Recall MedikMark and Maxxim | |
Date Initiated by Firm | July 12, 2004 |
Date Posted | July 22, 2004 |
Recall Status1 |
Terminated 3 on June 27, 2006 |
Recall Number | Z-1138-04 |
Recall Event ID |
29579 |
510(K)Number | K920340 |
Product Classification |
Drape, Surgical - Product Code KKX
|
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. |
Code Information |
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 |
Recalling Firm/ Manufacturer |
Medikmark, Incorporated 3600 Burwood Dr Waukegan IL 60085-8399
|
For Additional Information Contact | Ms. Rita Taylor 847-596-7723 |
Manufacturer 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. |
FDA Determined Cause 2 | 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 |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database | 510(K)s with Product Code = KKX
|
|
|
|