BEUDAMED
    FDA Recall Terminated

    REF 0562K (Adult Elongated O2/CO2 Mask - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.

    Recall: Z-0745-2021 · Initiated November 11, 2020

    Recall

    Recall Number
    Z-0745-2021
    Event Number
    86903
    Firm
    Westmed, Inc.
    FEI Number
    1000374126
    Product Code
    KGB
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 11, 2020
    Terminated
    February 7, 2023
    Address
    5580 S Nogales Hwy, Ste 170, Tucson, AZ, 85706-3333

    Description

    REF 0562K (Adult Elongated O2/CO2 Mask - 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.

    Action

    On November 11, 2020, West Med, Inc. issued a recall notification for oxygen delivery products via E-Mail to affected consignees. In addition to informing consignees about the recall products, the firm asked consignees to take the following actions: 1. Please complete the attached response form and quarantine affected product. 2. DO NOT DESTROY OR DISPOSE OF PRODUCT AT THIS TIME. 3. Contact Kalyn Galvez-Latneau, Westmed Customer Service Manager, for additional information and to obtain a Return Material Authorization (RMA). Kalyn Galvez-Latneau, [email protected], (520) 294-7987, Ext 1232.

    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

    16,000 units