Staple Removal Set/Kit; a sterile Rx convenience kit containing a staple remover and a gauze sponge. Theses kits were ma
FDA device recall Z-1138-04 · posted 2004-07-22 · Terminated
Recall details
- Recalling firm
- Medikmark, Incorporated
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- KKX
- Quantity affected
- 724,800 kits
- Distribution
- Nationwide
- Date initiated
- 2004-07-12
- Date posted
- 2004-07-22
- Date terminated
- 2006-06-27
- Location
- Waukegan, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SUTURE REMOVAL KIT (K920340) | Medikmark, Inc. | 1992-04-23 |