Z-2248-2023 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- August 30, 2023
- Initiation Date
- July 12, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,621 units
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.
Distribution Pattern
US Nationwide Distribution.
Code Information
Part No. 5704110; UDI-DI 04048675398516; All Serial No.