FDA-Device2022-01-19Class II
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.
Ohio Medical Corporation
Hazard
Increase in premature device failures
Sold states
US Nationwide, including PR. There was government and foreign distribution. There was no military distribution.
Affected count
649 portable suction pumps and replacement pumps
Manufactured in
1111 Lakeside Dr, N/A, Gurnee, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0482-2022Don't want to check this manually?
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