MIRA CR4060 68 mm Finger Probe 68mm surf ace x 37mm Length Intended for the destruction of tumors.
FDA device recall Z-1920-2010 · posted 2010-06-29 · Terminated
Recall details
- Recalling firm
- Mira, Inc.
- Reason for recall
- Devices distributed without an approved 510(k)
- Action taken
- Mira contacted accounts by email between 4/08/10-05/21/10 requesting return of inventory.
- Root cause
- PMA
- Status
- Terminated
- Product code
- HPS
- Quantity affected
- 5 units
- Distribution
- Worldwide Distribution -- USA, including the state of NY and the countries of Israel and Italy.
- Date initiated
- 2010-04-08
- Date posted
- 2010-06-29
- Date terminated
- 2016-08-08
- Location
- Uxbridge, MA
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