CLASS I ONGOING Device recall · Reported 30 Aug 2023 · FDA Enforcement Report
Carina Sub-Acute Care Ventilator recalled by Draeger Medical
Draeger Medical is recalling Carina Sub-Acute Care Ventilator, distributed nationwide in the US. The recall was initiated on 12 Jul 2023 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2248-2023
- FDA event ID
- 92629
- Recalling firm
- Draeger Medical, Telford, PA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 12 Jul 2023
- FDA classified
- 18 Aug 2023
- Reported
- 30 Aug 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- CPAP & Ventilators
Timeline
| 12 Jul 2023 | Recall initiated by company | |
| 18 Aug 2023 | Classified by FDA | +37 days |
| 30 Aug 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
Carina Sub-Acute Care Ventilator
Where it was distributed
US Nationwide Distribution.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Part No. 5704110; UDI-DI 04048675398516; All Serial No.
Where was it sold?
US Nationwide Distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Draeger Medical
All 78| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Atlan A300 recalled by Draeger Medical | Draeger Medical | Device Malfunction | PA |
| Device | CLASS I | Atlan A300XL recalled by Draeger Medical | Draeger Medical | Device Malfunction | PA |
| Device | CLASS I | Atlan A350 recalled by Draeger Medical | Draeger Medical | Device Malfunction | Nationwide |
| Device | CLASS I | Atlan A350XL recalled by Draeger Medical | Draeger Medical | Device Malfunction | Nationwide |
| Device | CLASS I | Dr¿ger Perseus A500 Anesthesia Workstation recalled by Draeger Medical | Draeger Medical | Device Malfunction | Nationwide |
Other CPAP & Ventilators recalls
All 552| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | Getinge Y Sensor Module, Servo-u, Servo recalled | Maquet Critical Care AB | Device Malfunction | Nationwide |
| Device | CLASS II | Biofire Respiratory Panel 2.1 (RP2.1) recalled by BioFire Diagnostics | BioFire Diagnostics | Other | Nationwide |
| Device | CLASS I | Astral 100/150 Resmed Astral 100/50 is a ventilator system recalled | ResMed | Packaging Defects | Nationwide |
| Device | CLASS I | Breathing circuit set, coaxial recalled by Hamilton Medical AG | Hamilton Medical | Device Malfunction | Nationwide |