Class I — Draeger Medical, Inc.
| Recalling firm | Draeger Medical Systems, Inc. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Ongoing |
| 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. |
| Product | Carina Sub-Acute Care Ventilator |
| Quantity | 11,621 units |
| Distribution | US Nationwide Distribution. |
| Initiated | 2023-07-12 |
| Classified | 2023-08-18 |
| Recall number | Z-2248-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Draeger Medical, Inc. (Z-2248-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/92629/
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