BEUDAMED
    FDA Enforcement Class II Ongoing

    CooperSurgical H/S CATHETER SET FR 5 with Integated Stylet Model: 61-4005S For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology such as polyps, fibroids, adhesions or endometrial thickening, and/or patency of fallopian tubes

    Recall: Z-0504-2024 · Reported December 13, 2023

    Enforcement

    Recall Number
    Z-0504-2024
    Event ID
    93239
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    CooperSurgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 13, 2023
    Initiation Date
    March 31, 2022
    Classification Date
    December 6, 2023
    Address
    95 Corporate Dr, Trumbull, CT, 06611-1350, United States

    Description

    CooperSurgical H/S CATHETER SET FR 5 with Integated Stylet Model: 61-4005S For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology such as polyps, fibroids, adhesions or endometrial thickening, and/or patency of fallopian tubes

    Reason

    Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay of procedure

    Code Info

    UDI-DI: 60888937016453 S/N: 309967

    Distribution

    Nationwide Foreign: BELGIUM CANADA MALAYSIA NETHERLANDS SPAIN SWEDEN SWITZERLAND

    Quantity

    90 units