Ohio Medical Corporation recalls Portable Suction Pump, (a) Style 758010, Model CARE-E-VAC 3, Ohio Medical LLC; (b) Style 758000, Model CARE-E-VAC 3, Oh…

Recall date

August 14, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2995-2018

FDA classification

Class II

Brand / firm

Ohio Medical Corporation

Sold / distributed

US Nationwide Distribution and internationally to countries: Canada, Saudi Arabia, and United Arab Emirates.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Portable Suction Pump, (a) Style 758010, Model CARE-E-VAC 3, Ohio Medical LLC; (b) Style 758000, Model CARE-E-VAC 3, Ohio Medical LLC The care-e-(R)3 is a portable medical aspirator used to suction fluids or foreign bodies from a patient. The primary intended use is to aspirate saliva, mucous, vomitus or other aspirant from the mouth or airway to allow adequate respiration or ventilation of the patient.