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Recall Observatory FDA recall evidence

Device product

Carina Sub-Acute Care Ventilator

Z-2248-2023

July 12, 2023

Class I

Product summary

Firm
Draeger Medical, Inc.
Event
Event 92629
Status
Ongoing
Classification
Class I
Quantity
11,621 units
Official record key
device-enforcement:Z-2248-2023

Official wording

Reason: 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.

Code information: Part No. 5704110; UDI-DI 04048675398516; All Serial No.

Distribution pattern: US Nationwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.