BEUDAMED
    FDA Enforcement Class II Terminated

    COUDE Blunt Nerve Block Needle, 10 units, 0.71mm (22 Ga) x 152mm, Each Unit Contains One Blunt Nerve Block Needle and One Wing, Sterile

    Recall: Z-0088-2018 · Reported November 15, 2017

    Enforcement

    Recall Number
    Z-0088-2018
    Event ID
    77842
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Epimed International
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    November 15, 2017
    Initiation Date
    July 24, 2017
    Classification Date
    November 9, 2017
    Termination Date
    July 6, 2023
    Address
    13958 Diplomat Dr, N/A, Farmers Branch, TX, 75234-8805, United States

    Description

    COUDE Blunt Nerve Block Needle, 10 units, 0.71mm (22 Ga) x 152mm, Each Unit Contains One Blunt Nerve Block Needle and One Wing, Sterile

    Reason

    Potential for partially incomplete seal of product, impacting sterility.

    Code Info

    Lot No. 12608201; Ref No. 117-2260.

    Distribution

    Domestic: AR, CA, IA, IN, KY, LA, MI, NY, OH, OR, TN, TX, & WA. Foreign: Canada, Czech Republic, Germany ,& Turkey.

    Quantity

    300 units