Recall Z-0770-2007 ยท FEB Accessories, Cleaning, For Endoscope
Custom Ultrasonics, Inc.
83 plus Mini-flex with accessory crate, Custom Ultrasonics, Inc.
| Date | May 4, 2007 (initiated Dec 12, 2005) |
| Status | Terminated |
| Reason | The device was marketed without a 510k |
| Root cause | PMA |
| Action | 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. |
| Quantity | 4 units |
| Distribution | Worldwide-The device was shipped to medical facilities in CA, GA, VA. and the UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061430 | SYSTEM 83 PLUS MINIFLEX WASHER-DISINFECTOR Custom Ultrasonics, Jan 12, 2007 |