medical Class II Updated 2018-07-18

Ohio Medical Corporation recalls Vacuum Regulator, Push-T-Set Intermittent Suction Unit (PTS-

Recalled 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.

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: 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

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