BEUDAMED
    FDA Recall 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 · Initiated July 24, 2017

    Recall

    Recall Number
    Z-0087-2018
    Event Number
    77842
    Firm
    Epimed International
    FEI Number
    1643059
    Product Code
    OGE
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    July 24, 2017
    Terminated
    July 6, 2023
    Address
    13958 Diplomat Dr, Farmers Branch, TX, 75234-8805

    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.

    Action

    Consignees were contacted 07/24/2017 via email and phone, notifying them of the recall. Consignees were asked to contact the recalling firm to report the number of affected product on hand. A second, updated recall notification was sent on 08/04/2017. Instructions included to examine inventory and quarantine any affected product, contact Epimed to arrange return/credit of the affected product, and complete and return the response form.

    Distribution

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

    Quantity

    500 units