Reported Jul 18, 2018 · Terminated
Vacuum Regulator, Push-T-Set Intermittent Suction Unit (PTS-ISU) Product Usage: The vacuum regulator is intended to be…
Ohio Medical Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ohio Medical Corporation · 1111 Lakeside Dr · Gurnee, IL · 60031-2489
Is this the product you have?
- Vacuum Regulator, Push-T-Set Intermittent
- Suction Unit (PTS-ISU) Product UsageThe vacuum regulator is intended to be used in a medical facility as a means to evacuate media (i.e. fluids) from the body
- Lot codes and dates
UDI 08688250002085Catalog Numbers 8702-1251-9088701-1251-9018705-1251-9078701-1251-9088705-1251-901Lot Number ISU177359Device Unit Numbers JGGW24156JGGW24193JGGW24157JGGW24161JGGW24167JGGW24169JGGW24175JGGW24188JGGW24189JGGW24198JGGW24160
- Amount recalled
- 11 units
Where it was sold
Why it was recalled
Final quality control testing was not completed before the devices were distributed..
This product could cause temporary or reversible health problems — stop using it.
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