BEUDAMED
    FDA Enforcement Class II 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 · Reported November 9, 2016

    Enforcement

    Recall Number
    Z-0086-2017
    Event ID
    74018
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Epimed International, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 9, 2016
    Initiation Date
    April 22, 2016
    Classification Date
    October 31, 2016
    Termination Date
    June 14, 2018
    Address
    141 Sal Landrio Dr, Crossroads Business Park, Johnstown, NY, 12095-3835, United States

    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.

    Code Info

    1) Spectra Lot# GC091702 (Epimed manufacturing lot # 2801501, Sterile Lot # 12157181) 2) Spectra Lot# GC101871 (Epimed manufacturing lot # 3211503, Sterile Lot # 12157445) 3) Spectra Lot# GC101897 (Epimed manufacturing lot # 3161501, Sterile Lot # 12157325)

    Distribution

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

    Quantity

    576 units