# FDA recall Z-2248-2023

> **Draeger Medical, Inc.** · Class I · device recall initiated 2023-07-12.

## 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.

## Distribution

US Nationwide Distribution.

## Key facts

- **Recall number:** Z-2248-2023
- **Recalling firm:** Draeger Medical, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-07-12
- **Report date:** 2023-08-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Telford, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2248-2023

## Citation

> AI Analytics. FDA recall Z-2248-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2248-2023. Source: US FDA. Licensed CC0.

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