Carina Sub-Acute Care Ventilator Recalled for Toxic Chemical Emission
Draeger Medical is recalling 11,621 Carina Sub-Acute Care Ventilators because polyurethane components emit 1,3-Dichloropropan-2-ol at levels exceeding safe limits during extended use in pediatric patients.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall, which requires a minimum severity score of Severe. Although no illnesses or injuries are reported in the source, the chemical hazard involving toxic emission in pediatric patients during extended mechanical ventilation (>30 days) represents a serious health risk.
Plain-English summary
Draeger Medical, Inc. is recalling 11,621 units of the Carina Sub-Acute Care Ventilator distributed nationwide across the United States. The ventilator provides mechanical respiratory support to patients in sub-acute care settings.
The recall is due to polyether polyurethane components that emit 1,3-Dichloropropan-2-ol at levels exceeding the acceptable uptake threshold. This chemical exposure occurs during continuous use lasting more than 30 days.
Pediatric patients requiring extended mechanical ventilation are the population at risk from elevated chemical exposure. All serial numbers of this ventilator model are affected by this recall.
Patients and healthcare facilities currently using this ventilator should contact Draeger Medical for instructions regarding the affected units.
The recalled product
- Product
- Carina Sub-Acute Care Ventilator
- Manufacturer
- Draeger Medical, Inc.
- Affected units
- 11,621
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Part No. 5704110
- UDI-DI 04048675398516
- All Serial No.
Distribution
Distributed nationwide across the United States.
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