BEUDAMED
    FDA Enforcement Class II Terminated

    TUOHY Epidural Needle, 20g x 3.5in(8.9cm) TW, 10 units, Calibrated, Plastic Hub, Fixed Wing, Sterile, Rx only

    Recall: Z-0089-2018 · Reported November 15, 2017

    Enforcement

    Recall Number
    Z-0089-2018
    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

    TUOHY Epidural Needle, 20g x 3.5in(8.9cm) TW, 10 units, Calibrated, Plastic Hub, Fixed Wing, Sterile, Rx only

    Reason

    Potential for partially incomplete seal of product, impacting sterility.

    Code Info

    Lot No. 12358202; Ref No. 125-2035T.

    Distribution

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

    Quantity

    263 units