BEUDAMED
    FDA Recall 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 · Initiated November 15, 2019

    Recall

    Recall Number
    Z-0930-2020
    Event Number
    84296
    Firm
    Tytek Medical Inc
    FEI Number
    3004551550
    Product Code
    BWC
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 15, 2019
    Posted
    February 12, 2020
    Terminated
    October 1, 2020
    Address
    4700 Ashwood Dr, Ste 445, Blue Ash, OH, 45241-2684

    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.

    Action

    On November 15, 2019, Tytek Medical issued an Urgent Medical Device Recall notices and Return Response forms to customers. Customers were advised to take the following actions: 1) Please do not use any of the product from the affected lot. 2) Please recall this product from your points of distribution and return it immediately. 3) Product may be returned to Tytek Medical via UPS Account # R5513V or DHL Account # 958855282 to: Tytek Medical 4700 Ashwood Drive Ste 445, Cincinnati, OH 45241; (513) 874-7326 4) Complete and return the Instructions for Acknowledgement form via fax to (513) 874-7294; or via email to [email protected] Customers with questions or concerns may call (513) 872-7326 Monday through Friday 8 am - 5 pm, EST.

    Distribution

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

    Quantity

    3,565 units