Recall Z-0482-2022
Ohio Medical Corporation · initiated November 16, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Shipped between March 2019 and February 2021.
Reason for recall
Increase in premature device failures
FDA-determined cause: Employee error
Action taken
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.
Details
- Recall number
- Z-0482-2022
- Initiated
- November 16, 2021
- Product code
- BTA – Pump, Portable, Aspiration (Manual Or Powered)
- Quantity
- 649 portable suction pumps and replacement pumps
- Distribution
- US Nationwide, including PR. There was government and foreign distribution. There was no military distribution.
- Recalling firm
- Ohio Medical Corporation, Gurnee, IL