Ohio Medical Corporation recalls Vacuum Regulator, Push-T-Set Intermittent Suction Unit (PTS-ISU) Product Usage: The vacuum regulator is intended to be…

Recall date

March 12, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2410-2018

FDA classification

Class II

Brand / firm

Ohio Medical Corporation

Sold / distributed

US Nationwide Distribution in the states of NC, IN, TN, LA,, FL MI, IL.

Why it was recalled

Final quality control testing was not completed before the devices were distributed..

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Vacuum Regulator, Push-T-Set Intermittent Suction Unit (PTS-ISU) Product Usage: The vacuum regulator is intended to be used in a medical facility as a means to evacuate media (i.e. fluids) from the body.