PlainRecalls
FDA Devices Moderate Class II Ongoing

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.

Reported: January 19, 2022 Initiated: November 16, 2021 #Z-0482-2022

Product 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 for Recall

Increase in premature device failures

Details

Recalling Firm
Ohio Medical Corporation
Units Affected
649 portable suction pumps and replacement pumps
Distribution
US Nationwide, including PR. There was government and foreign distribution. There was no military distribution.
Location
Gurnee, IL

Frequently Asked Questions

What product was recalled?
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.. Recalled by Ohio Medical Corporation. Units affected: 649 portable suction pumps and replacement pumps.
Why was this product recalled?
Increase in premature device failures
Which agency issued this recall?
This recall was issued by the FDA Devices on January 19, 2022. Severity: Moderate. Recall number: Z-0482-2022.