Recall Z-0767-2007 ยท GES Blade, Scalpel
Miltex, Inc.
Miltex Stainless Steel Disposable Scalpel #22, Part Number 4-422. Each box contains 10 individually packaged scalpels.
| Date | Apr 21, 2007 (initiated Apr 9, 2007) |
| Status | Terminated |
| Reason | Sterility may be compromised based on incomplete package seals (manufacturer notified Miltex) |
| Root cause | Other |
| Action | The recalling firm issued a recall letter dated 4/9/07 informing the customers of the problem and the need to return the product. The letter was sent via UPS with a return receipt required to verify delivery. Distributors were notified to sub-recall. |
| Quantity | 400 boxes |
| Distribution | Nationwide to distributors in CA, FL, IA, ID, NM, NJ, OH, PA, RI, and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.