Recall Z-1920-2010 ยท HPS Unit, Cryophthalmic
Mira, Inc.
MIRA CR4060 68 mm Finger Probe 68mm surf ace x 37mm Length Intended for the destruction of tumors.
| Date | Jun 29, 2010 (initiated Apr 8, 2010) |
| Status | Terminated |
| Reason | Devices distributed without an approved 510(k) |
| Root cause | PMA |
| Action | Mira contacted accounts by email between 4/08/10-05/21/10 requesting return of inventory. |
| Quantity | 5 units |
| Distribution | Worldwide Distribution -- USA, including the state of NY and the countries of Israel and Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.