BEUDAMED
    FDA Enforcement Class II Terminated

    Neo-Vent Infant T-Piece Resuscitation Circuit With Neonatal Mask; Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF 0421, Qty:10, Length: 60" (1.5cm), Rx Only.

    Recall: Z-2436-2020 · Reported July 8, 2020

    Enforcement

    Recall Number
    Z-2436-2020
    Event ID
    85576
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Westmed, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 8, 2020
    Initiation Date
    January 15, 2019
    Classification Date
    June 26, 2020
    Termination Date
    February 5, 2021
    Address
    5580 S Nogales Hwy Ste 170, N/A, Tucson, AZ, 85706-3333, United States

    Description

    Neo-Vent Infant T-Piece Resuscitation Circuit With Neonatal Mask; Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF 0421, Qty:10, Length: 60" (1.5cm), Rx Only.

    Reason

    A repair was made to an adapter mold resulting in parts being produced with compliant 10mm ID connections and non-compliant 15mm OD connections. This resulted in facilities with infant resuscitators that connect via the 15mm OD fitting not being able to use those circuits.

    Code Info

    101518U04, 102318U07, 101618U03.

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of CA, GA, IL,OH, MA, MI, MO, NC, OH, OR, TX, VA, and WI. The country of Spain.

    Quantity

    48 cases