Carina Sub-Acute Care Ventilator — Class I medical device recall Z-2248-2023
Ongoing recall by Draeger Medical, Inc., reported 2023-08-30, distributed nationwide. Presence of polyether polyurethane (PE-PUR) and emission of 1,3-Dichloropropan-2-ol that exceed the acceptable
| Recall number | Z-2248-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Draeger Medical, Inc., Telford, PA, United States |
| Recall initiated | 2023-07-12 |
| Classified | 2023-08-18 |
| Reported by FDA | 2023-08-30 |
| Distributed | Nationwide (US) |
| Quantity | 11,621 units |
| UPC / GTIN / UDI-DI | 04048675398516 |
| Model numbers | 5704110 |
Product
Carina Sub-Acute Care Ventilator
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2248-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.