83 plus Mini-flex with accessory crate, Custom Ultrasonics, Inc.
FDA device recall Z-0770-2007 · posted 2007-05-04 · Terminated
Recall details
- Recalling firm
- Custom Ultrasonics, Inc.
- Reason for recall
- The device was marketed without a 510k
- Action taken
- On 12/12/05, the recalling firm telephoned their sales representatives to inform them of the problem. Letter were hand delivered to the hospitals by the sales representatives.
- Root cause
- PMA
- Status
- Terminated
- Product code
- FEB
- Quantity affected
- 4 units
- Distribution
- Worldwide-The device was shipped to medical facilities in CA, GA, VA. and the UK.
- Date initiated
- 2005-12-12
- Date posted
- 2007-05-04
- Date terminated
- 2013-02-20
- Location
- Ivyland, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYSTEM 83 PLUS MINIFLEX WASHER-DISINFECTOR (K061430) | Custom Ultrasonics | 2007-01-12 |