Ohio Medical Vacuum Regulator Recalled for Incomplete Quality Control Testing
Ohio Medical Corporation is recalling 11 Vacuum Regulator units because final quality control testing was not completed before distribution.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a procedural failure (incomplete testing) rather than a confirmed defect causing harm, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Ohio Medical Corporation is recalling 11 units of the Vacuum Regulator, Push-T-Set Intermittent Suction Unit (PTS-ISU). These devices are intended for use in medical facilities to evacuate fluids from the body.
The recall was initiated because final quality control testing was not completed before the devices were distributed. The affected units were distributed nationwide in North Carolina, Indiana, Tennessee, Louisiana, Florida, Michigan, and Illinois.
Healthcare facilities should stop using the affected units and contact Ohio Medical Corporation for further instructions. The specific units are identified by UDI 08688250002085, Lot Number ISU177359, and specific device unit numbers listed in the recall documentation.
The recalled product
- Product
- 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.
- Manufacturer
- Ohio Medical Corporation
- Hazard
- Affected units
- 11
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (18)
- UDI 08688250002085
- Catalog Numbers 8702-1251-908
- 8701-1251-901
- 8705-1251-907
- 8701-1251-908
- 8705-1251-901
- Lot Number ISU177359
- Device Unit Numbers JGGW24156
- JGGW24193
- JGGW24157
- JGGW24161
- JGGW24167
- JGGW24169
- JGGW24175
- JGGW24188
- JGGW24189
- JGGW24198
- JGGW24160
Distribution
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