BEUDAMED
    FDA Recall Terminated

    Feth-R-Kath Catheter, 19g x 24". Intended Use:Radlo Opaque Epidural Catheter Catalog #: 157-1924 Intended for epidural anesthesia and is limited to placement of 72 hours or less

    Recall: Z-1276-2021 · Initiated February 1, 2021

    Recall

    Recall Number
    Z-1276-2021
    Event Number
    87333
    Firm
    Epimed International, Inc.
    FEI Number
    1316297
    Product Code
    BSO
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 1, 2021
    Terminated
    October 17, 2022
    Address
    141 Sal Landrio Dr, Johnstown, NY, 12095-3835

    Description

    Feth-R-Kath Catheter, 19g x 24". Intended Use:Radlo Opaque Epidural Catheter Catalog #: 157-1924 Intended for epidural anesthesia and is limited to placement of 72 hours or less

    Reason

    Outer coating of the catheter may deteriorate and result in the coating to crack and/or potentially flake off

    Action

    Epimed issued an " URGENT: MEDICAL DEVICE RECALL" letter on 2/1/21via US Mail. Letter states reason for recall, health risk and Actions to be taken by the Customer/User: " Immediately examine your inventory and quarantine product subject to recall. o In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. " Your notification to your customers may be enhanced by including a copy of this recall notification letter. " Once the product has been quarantined, please complete the Recall Response Form in its entirety- indicating product quantity/disposition, and return the enclosed response form as soon as possible. Epimed Contact Information: In addition, please contact our Sales Administrative Assistant, Bobbi Harrington at (518) 848-3914 or [email protected], so that we can arrange for replacement or credit of the affected product. Contact hours are from 6:00am - 4:00pm EST.

    Distribution

    US Nationwide distribution

    Quantity

    5835 units