Recall Z-0482-2022 ยท BTA Pump, Portable, Aspiration (Manual Or Powered)
Ohio Medical Corporation
Instavac Portable Suction Pump, Constant mode (model #757000, Instavac C) and Intermittent mode (model 756000, Instavac I); and Instavac replacement pumps, part #AI5511, a component of model numbers 756000 and 757000.
| Date | Nov 16, 2021 |
| Status | Open, Classified |
| Reason | Increase in premature device failures |
| Root cause | Employee error |
| Action | The firm notified their consignees by letter beginning 11/16/2021 via USPS. The letter identified the defect and requested the return of the affected devices for testing unless it is not feasible to do so. Consignees were provided an alternative option for on site testing if the device could not be returned. |
| Quantity | 649 portable suction pumps and replacement pumps |
| Distribution | US Nationwide, including PR. There was government and foreign distribution. There was no military distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K933902 | MOBLVAC III Aeros Instruments, Inc., May 20, 1994 |