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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Ohio Medical Corporation
- Reason for Recall:
- Final quality control testing was not completed before the devices were distributed..
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2410-2018
Related Recalls
Erroneous calibration values, potentially resulting in: as the device ages, oxygen purity will gradually decrease to the point where the device alarms to indicate low oxygen purity will be incorrect.
Increase in premature device failures
The care-e-vac(R)3 Battery/AC Powered Portable Aspirator battery terminal may come in contact with the pump causing an electric short leading to damage to wiring and resulting in loss of function or an inoperable unit under battery power.