BEUDAMED
    FDA Enforcement Class II Terminated

    RX-2 COUDE Epidural Needle, 16g x 3.5in (8.9cm)TW, 10 units, Calibrated, Plastic Hub, Detachable Wing, Blunt Stylet, Sterile, Rx only, For Use with 19g or Smaller Catheter

    Recall: Z-0087-2018 · Reported November 15, 2017

    Enforcement

    Recall Number
    Z-0087-2018
    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

    RX-2 COUDE Epidural Needle, 16g x 3.5in (8.9cm)TW, 10 units, Calibrated, Plastic Hub, Detachable Wing, Blunt Stylet, Sterile, Rx only, For Use with 19g or Smaller Catheter

    Reason

    Potential for partially incomplete seal of product, impacting sterility.

    Code Info

    Lot No. 12168200; Ref No. 107-1416.

    Distribution

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

    Quantity

    500 units