Carina Sub-Acute Care Ventilator
Reported: August 30, 2023 Initiated: July 12, 2023 #Z-2248-2023
Product Description
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.
Details
- Recalling Firm
- Draeger Medical, Inc.
- Units Affected
- 11,621 units
- Distribution
- US Nationwide Distribution.
- Location
- Telford, PA
Frequently Asked Questions
What product was recalled? ▼
Carina Sub-Acute Care Ventilator. Recalled by Draeger Medical, Inc.. Units affected: 11,621 units.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on August 30, 2023. Severity: Critical. Recall number: Z-2248-2023.
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