BEUDAMED
    FDA Enforcement Class II Terminated

    REF 0930 Adult Elongated CO2/O2 Mask, 7' Tubing w/ Threaded Nut, Sivel GSE, 10' GSL X .038" ID X .107" OD, Reflective Luer Connectors, Rx Only, CE0482, (01)00709078005718 - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.

    Recall: Z-0743-2021 · Reported January 6, 2021

    Enforcement

    Recall Number
    Z-0743-2021
    Event ID
    86903
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Westmed, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 6, 2021
    Initiation Date
    November 11, 2020
    Classification Date
    December 29, 2020
    Termination Date
    February 7, 2023
    Address
    5580 S Nogales Hwy Ste 170, N/A, Tucson, AZ, 85706-3333, United States

    Description

    REF 0930 Adult Elongated CO2/O2 Mask, 7' Tubing w/ Threaded Nut, Sivel GSE, 10' GSL X .038" ID X .107" OD, Reflective Luer Connectors, Rx Only, CE0482, (01)00709078005718 - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.

    Reason

    There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection to the mask adapter resulting in a possible delay in treatment.

    Code Info

    Lot # 091620N04

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of PA, OK, MO, CO, RI, IL, CA, TX, OH, MD, IL, MN, KS and the countries of Canada, Korea, United Kingdom

    Quantity

    600 units