Recall Z-0522-2010 ยท GES Blade, Scalpel
Merit Medical Systems, Inc.
Merit Medical Systems, Inc. Futura Safety Scalpels, Futura Safety Scalpel REF/CAT No SMS210 Used for cutting tissue in surgical and laboratory procedures.
| Date | Dec 14, 2009 (initiated Sep 29, 2009) |
| Status | Terminated |
| Reason | Potential sterility breach caused by excessive shipment damage. |
| Root cause | Other |
| Action | Merit Medical Customers were contacted directly by phone and letter on 9/29/09. Customers were instructed to identify and quarantine all unused affected product. Further information was available at 801-208-4365. |
| Quantity | 100 scalpels |
| Distribution | US (AL, LA, MO, KY, TN, GA). No military, government or foreign distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K923170 | LOS ALAMOS RETRACTABLE KNIFE Innovative Surgical Technology, Inc., Feb 18, 1993 |