FDA Device recall Z-2248-2023
Carina Sub-Acute Care Ventilator
- FDA Device
- Class I
- ongoing
- Published 2023-08-30
On 2023-08-30 the FDA classified a Class I recall of Carina Sub-Acute Care Ventilator by Draeger Medical, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2248-2023 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-07-12 |
| Published | 2023-08-30 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Draeger Medical |
| Distribution | US |
Product
Carina Sub-Acute Care Ventilator
Reason
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.
Identifiers
| code_info | Part No. 5704110; UDI-DI 04048675398516; All Serial No. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2248-2023%22
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