BEUDAMED
    FDA Recall Open, Classified

    Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781035

    Recall: Z-1951-2023 · Initiated May 25, 2023

    Recall

    Recall Number
    Z-1951-2023
    Event Number
    92373
    Firm
    TELEFLEX LLC
    FEI Number
    3005747797
    Product Code
    BTR
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    May 25, 2023
    Posted
    June 29, 2023
    Address
    3015 Carrington Mill Blvd, Morrisville, NC, 27560-5437

    Description

    Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781035

    Reason

    Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

    Action

    Teleflex issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 05/25/2012 by FedEx. The notice explained the problem, the risk, and requested the following: Users should cease use and distribution of affected product and immediately quarantine the affected product. Distributors were directed to cease use, distribution, and quarantine the product, and to notify their customers. Teleflex is seeking the return of the affected product. For further information: Contact: Customer Service, Telephone: 1-866-396-2111 FAX: 1-855-419-8507, Email: [email protected]

    Distribution

    US Nationwide distribution including Puerto Rico.

    Quantity

    76060 units