BEUDAMED
    FDA Recall Completed

    NEO-KATH Epidural Catheter Set, REF 200-2430, Sterile

    Recall: Z-2312-2021 · Initiated December 28, 2017

    Recall

    Recall Number
    Z-2312-2021
    Event Number
    88317
    Firm
    Epimed International
    FEI Number
    1643059
    Product Code
    BSO
    Status
    Completed
    Root Cause
    Process control
    Initiated
    December 28, 2017
    Address
    13958 Diplomat Dr, Farmers Branch, TX, 75234-8805

    Description

    NEO-KATH Epidural Catheter Set, REF 200-2430, Sterile

    Reason

    Potential for stylet to protrude from the distal end of the catheter

    Action

    On about 12/28/2017, Epimed mailed their recall notification letter titled, URGENT Medical Device RECALL, to customers. Those letters were followed up with a telephone call or email containing the letter on about 12/30/2017. The letter explained the issue and hazard and requested that if any potentially affected product remains in the accounts inventory, Epimed will offer to replace/credit the affected product. Each customer was asked to complete and return the RECALL RETURN RESPONSE FORM as soon as possible.

    Distribution

    Worldwide distribution, with US distribution to CA, DE, OH, OK, PA, VA, WA, WV. International distribution to Canada and Iran.

    Quantity

    132 units