BEUDAMED
    FDA Recall Terminated

    15 g R.K. Epidural Needle (TW), Catalog #/REF #100-1415 Intended for the epidural placement, directly or through an epidural catheter, of anesthetic agents to elicit regional anesthesia

    Recall: Z-0086-2017 · Initiated April 22, 2016

    Recall

    Recall Number
    Z-0086-2017
    Event Number
    74018
    Firm
    Epimed International, Inc.
    FEI Number
    1316297
    Product Code
    BSP
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    April 22, 2016
    Terminated
    June 14, 2018
    Address
    141 Sal Landrio Dr, Crossroads Business Park Johnstown, NY, 12095-3835

    Description

    15 g R.K. Epidural Needle (TW), Catalog #/REF #100-1415 Intended for the epidural placement, directly or through an epidural catheter, of anesthetic agents to elicit regional anesthesia

    Reason

    There is a possibility that the needles may have the potential to skive a catheters outer coating. If this were to occur, there exists the risk that a portion of the catheter could remain in the patient, which may require otherwise unnecessary medical invention.

    Action

    On April 22, 2016, Epimed sent an Urgent Medical Device Recall notices and Recall Return Response Forms to their customers via courier service. Customers were advised to examine all inventory and quarantine product subject to recall immediately. Once the product has been quarantined, please complete and return the enclosed response form as soon as possible by fax to: 518-725-0207, Attn: Quality Assurance. In addition, if you find any product that corresponds to the lot numbers given, please contact the Customer Service Department so that Epimed can arrange for replacement/credit (518-725-0209 or 518-514-1891). Further questions, please call (518) 725-0209.

    Distribution

    US Distribution to the states of : AL, AK, FL, IN, TN & TX

    Quantity

    576 units