FDA-Device2018-07-18Class II
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.
Ohio Medical Corporation
Hazard
Final quality control testing was not completed before the devices were distributed..
Sold states
US Nationwide Distribution in the states of NC, IN, TN, LA,, FL MI, IL.
Affected count
11 units
Manufactured in
1111 Lakeside Dr, Gurnee, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2410-2018Don't want to check this manually?
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