BEUDAMED
    FDA Recall Open, Classified

    AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8004

    Recall: Z-1065-2024 · Initiated January 10, 2024

    Recall

    Recall Number
    Z-1065-2024
    Event Number
    93821
    Firm
    Vyaire Medical
    FEI Number
    3013421741
    Product Code
    BTM
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    January 10, 2024
    Posted
    February 25, 2024
    Address
    26125 N Riverwoods Blvd, Mettawa, IL, 60045-3420

    Description

    AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8004

    Reason

    Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ventilation or no ventilation that may result in hypoventilation or hypoxia, and potentially lead to death. The mold/tooling used to produce the affected component was replaced in 2017.

    Action

    Vyaire issued an URGENT: Customer notification Letter to its consignees on 01/10/2024 via letter delivered by UPS Next Day Air. The notice explained the problem, complaints received, and requested the consignee discard or destroy all affected devices. If the consignee further distributed the product, they were directed to forward a copy of the notice to those parties.

    Distribution

    Worldwide distribution. US nationwide, Brazil, Canada, Switzerland, France, UK, Mexico, Netherlands, Saudi Arabia, Sweden, and South Africa

    Quantity

    1,800,000 units