Draeger Medical recalls pediatric ventilators due to chemical emissions exceeding safe levels during long-term use. Affected units may pose health risks for children.
Presence of polyether polyurethane (PE-PUR) and emission of 1,3-Dichloropropan-2-ol that exceed the acceptable uptake level during continuous use (>30 days) in pediatric patients.
Dra: Draeger Medical is recalling pediatric ventilators that could emit harmful chemicals when used for more than 30 days. This poses a health risk for children using the device long-term.
The ventilator emits a chemical called 1,3-Dichloropropan-2-ol that exceeds safe levels when used continuously for more than 30 days in children. This chemical buildup could cause health issues over time.
Pediatric patients using the Carina Sub-Acute Care Ventilator for extended periods (over 30 days) are at risk. Parents and caregivers of children with breathing issues are most affected.
Check for the model number 5704110 or the UDI-DI code 04048675398516 on the ventilator. All units with this specific serial number range are affected.
Identify the model number 5704110 or UDI-DI code 04048675398516 on the ventilator.
The recall specifically addresses pediatric patients using the ventilator for over 30 days. Adults are not affected.
Check for the model number 5704110 or the UDI-DI code 04048675398516 on the device.
The recall does not specify a remedy, so contact Draeger Medical directly for guidance.
We’ve drafted a message you can send Draeger Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2248-2023 — Draeger Medical Draeger Medical Hello, I own a Draeger Medical that is covered by recall Z-2248-2023 from Draeger Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
