FDA-Device2023-08-30Class I
Carina Sub-Acute Care Ventilator
Draeger Medical, Inc.
Hazard
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.
Sold states
US Nationwide Distribution.
Affected count
11,621 units
Manufactured in
3135 Quarry Rd, N/A, Telford, PA, United States
Products
Carina Sub-Acute Care Ventilator
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2248-2023Don't want to check this manually?
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