FDA Recall
Open, Classified
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.
Recall: Z-0482-2022
·
Initiated November 16, 2021
Recall
- Recall Number
- Z-0482-2022
- Event Number
- 88984
- Firm
- Ohio Medical Corporation
- FEI Number
- 1419185
- Product Code
- BTA
- Status
- Open, Classified
- Root Cause
- Employee error
- Initiated
- November 16, 2021
- Address
- 1111 Lakeside Dr, Gurnee, IL, 60031-2489
Description
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.
Reason
Increase in premature device failures
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.
Distribution
US Nationwide, including PR. There was government and foreign distribution. There was no military distribution.
Quantity
649 portable suction pumps and replacement pumps