Draeger Carina Ventilator Recalled Due to Valve Assembly Corrosion Risk
Draeger Medical is recalling eight Carina Ventilators because valve assembly corrosion may contaminate breathing gas.
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 involves a risk of harm (contaminated breathing gas) in a medical device where no specific injuries or illnesses have been reported in the source text, fitting the High severity criteria.
Plain-English summary
Draeger Medical, Inc. is recalling eight units of the Carina Ventilator (Catalog no. 5704110). These are long-term ventilators intended for use in hospitals by qualified medical personnel. The affected units were distributed to the states of Connecticut, Illinois, Minnesota, Nevada, South Dakota, and Washington.
The recall is being conducted because the valve assembly material may become corroded due to insufficient cleaning by a supplier. This corrosion creates a risk that the breathing gas in the affected devices may become contaminated.
Hospitals and medical facilities should identify any units with the following serial numbers: ASKM-0065, ASKM-0066, ASKM-0106, ASKM-0134, ASKM-0137, ASKM-0150, ASKM-0151, and ASKN-0009. Users should stop using these specific units and contact Draeger Medical for further instructions on the recall process.
The recalled product
- Product
- Carina Ventilator, ventilator. Catalog no. 5704110. Long-term ventilator for treatment in hospitals by a qualified medical personnel.
- Manufacturer
- Draeger Medical, Inc.
- Category
- Medical Device — Ventilator
- Hazard
- Affected units
- 8
Distribution
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