BEUDAMED
    FDA Recall Open, Classified

    HydroSil Go Intermittent Urinary Catheters, Catalog Numbers: a) REF 71808, b) REF 71810, c) REF 71812, d) REF 71814, e) REF 71816, f) REF 71818

    Recall: Z-1701-2023 · Initiated April 20, 2023

    Recall

    Recall Number
    Z-1701-2023
    Event Number
    92082
    Firm
    C.R. Bard Inc
    FEI Number
    1018233
    Product Code
    EZD
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    April 20, 2023
    Posted
    June 8, 2023
    Address
    8195 Industrial Blvd Ne, Covington, GA, 30014-1497

    Description

    HydroSil Go Intermittent Urinary Catheters, Catalog Numbers: a) REF 71808, b) REF 71810, c) REF 71812, d) REF 71814, e) REF 71816, f) REF 71818

    Reason

    Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that could impact product sterility.

    Action

    The firm issued an URGENT MEDICAL DEVICE RECALL to its consignee beginning on 04/20/2023 by Fed Ex and email. The notice explained the problem, risk, and requested the following actions be taken: Discontinue distribution of the product and dispose of all affected product, Distributors are directed to notify their customers. For further assistance please contact: 1-844-8BD- LIFE (1-844-823-5433) Say "Recall" when prompted; M-F 8am - 5pm CT

    Distribution

    Worldwide

    Quantity

    308520 devices