BEUDAMED
    FDA Enforcement Class II Terminated

    ET-20 Anesthesia Extension Tubes, 2.5 ml approximately, Sterile and Disposable, Wall Medical Inc., Made in China

    Recall: Z-0696-2016 · Reported February 10, 2016

    Enforcement

    Recall Number
    Z-0696-2016
    Event ID
    73046
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Global Healthcare Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    February 10, 2016
    Initiation Date
    January 6, 2016
    Classification Date
    February 3, 2016
    Termination Date
    March 25, 2016
    Address
    11350 Old Roswell Rd, Suite 700, Alpharetta, GA, 30009-2291, United States

    Description

    ET-20 Anesthesia Extension Tubes, 2.5 ml approximately, Sterile and Disposable, Wall Medical Inc., Made in China

    Reason

    Firm was notified of a potential product defect related to kinking (flattening) of anesthesia extension tubes which may represent a potential health hazard.

    Code Info

    Lot Number 1505201

    Distribution

    US Distribution to state of: GA only.

    Quantity

    2,000 cases (100 individual units per case)