BEUDAMED
    FDA Enforcement Class II Terminated

    Bioseal Trachea Extender 1/pl 50pk/Cs, REF TRAX01/50, LOT XXXX, STERILE EO, Single Use Only, Date of Manufacture XXXX, Expiration Date XXXX, LF, UDI: (01) 00630094916019 - Product Usage: Airway connectors intended to connect a breathing gas source to a tracheal tube, tracheostomy tube, or mask.

    Recall: Z-2795-2020 · Reported August 19, 2020

    Enforcement

    Recall Number
    Z-2795-2020
    Event ID
    85288
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bioseal Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 19, 2020
    Initiation Date
    August 15, 2019
    Classification Date
    August 13, 2020
    Termination Date
    March 4, 2021
    Address
    167 W Orangethorpe Ave, N/A, Placentia, CA, 92870-6922, United States

    Description

    Bioseal Trachea Extender 1/pl 50pk/Cs, REF TRAX01/50, LOT XXXX, STERILE EO, Single Use Only, Date of Manufacture XXXX, Expiration Date XXXX, LF, UDI: (01) 00630094916019 - Product Usage: Airway connectors intended to connect a breathing gas source to a tracheal tube, tracheostomy tube, or mask.

    Reason

    The reported stress crack in the port of the swivel elbow where the flip cap is inserted could result in leakage from the breathing system resulting in the prescribed ventilation not being delivered to the patient. These cracks could possibly leak if they reach a significant size and pose a serious heath risk to patient.

    Code Info

    Bioseal Part # TRAX01/50 Bioseal Lot #'s 400453, 400456, 400461, 400472, 400476

    Distribution

    US Nationwide distribution including in the state of CA.

    Quantity

    900 units