BEUDAMED
    FDA Enforcement Class I Terminated

    PneumoDart, 14 ga x 3.25in., REF TM-317 A compact, sterile, device intended for the introduction into the body to facilitate the removal of air from the pleural cavity as a result of a tension pneumothorax condition.

    Recall: Z-0930-2020 · Reported February 19, 2020

    Enforcement

    Recall Number
    Z-0930-2020
    Event ID
    84296
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Tytek Medical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 19, 2020
    Initiation Date
    November 15, 2019
    Classification Date
    February 12, 2020
    Termination Date
    October 1, 2020
    Address
    4700 Ashwood Dr Ste 445, Blue Ash, OH, 45241-2684, United States

    Description

    PneumoDart, 14 ga x 3.25in., REF TM-317 A compact, sterile, device intended for the introduction into the body to facilitate the removal of air from the pleural cavity as a result of a tension pneumothorax condition.

    Reason

    A defect involving an occluded needle was discovered during a training exercise.

    Code Info

    NSN 6515-01-655-9514 Lot number - 190524J69 Expiration Date - May 24, 2026

    Distribution

    US (nationwide), and countries of: Europe, Australia and Hong Kong.

    Quantity

    3,565 units