BEUDAMED
    FDA Enforcement Class I Ongoing

    Carina Sub-Acute Care Ventilator

    Recall: Z-2248-2023 · Reported August 30, 2023

    Enforcement

    Recall Number
    Z-2248-2023
    Event ID
    92629
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Draeger Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 30, 2023
    Initiation Date
    July 12, 2023
    Classification Date
    August 18, 2023
    Address
    3135 Quarry Rd, N/A, Telford, PA, 18969-1042, United States

    Description

    Carina Sub-Acute Care Ventilator

    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 Info

    Part No. 5704110; UDI-DI 04048675398516; All Serial No.

    Distribution

    US Nationwide Distribution.

    Quantity

    11,621 units