Ohio Medical Care-E-Vac 3 Portable Suction Pump Recall
Ohio Medical is recalling 1,443 Care-E-Vac 3 portable suction pumps because a battery terminal may contact the pump, causing an electric short and loss of function.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Ohio Medical Corporation is recalling 1,443 units of the Care-E-Vac 3 portable suction pump, including Style 758010 and Style 758000 models. The device is a portable medical aspirator used to suction fluids or foreign bodies from a patient's mouth or airway to allow adequate respiration or ventilation.
The recall is due to a defect where the battery terminal may come into contact with the pump. This contact can cause an electric short, leading to damage to the wiring and resulting in a loss of function or an inoperable unit when running on battery power.
The affected units were distributed nationwide in the United States and internationally to Canada, Saudi Arabia, and the United Arab Emirates. Consumers and healthcare facilities should check their serial numbers against the list provided in the official recall notice and contact Ohio Medical Corporation for instructions on how to proceed.
The recalled product
- Product
- 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…
- Manufacturer
- Ohio Medical Corporation
- Affected units
- 1,443
Distribution
Distributed nationwide across the United States.
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