BEUDAMED
    FDA Enforcement Class II Terminated

    HSG Trays/HS 5F Catheter Combo; HSG Procedure Tray+ Shapeable 5F HSG catheter. For hysterosonography and hysterosalpingography, gynecological use.

    Recall: Z-1481-2015 · Reported April 29, 2015

    Enforcement

    Recall Number
    Z-1481-2015
    Event ID
    70948
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Catheter Research, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 29, 2015
    Initiation Date
    April 7, 2015
    Classification Date
    April 21, 2015
    Termination Date
    July 17, 2015
    Address
    5610 W 82nd St, Indianapolis, IN, 46278-1300, United States

    Description

    HSG Trays/HS 5F Catheter Combo; HSG Procedure Tray+ Shapeable 5F HSG catheter. For hysterosonography and hysterosalpingography, gynecological use.

    Reason

    HSG Trays and Catheters were mislabeled. Trays with the flexible HS catheter were labeled as containing the shapeable, stiffer HS catheter, and vice versa.

    Code Info

    Model Number/Catalogue/Product Number: TMI1160; 61-5205; TMI1198; KM61-5205; 61-3205; Lot codes: J436A, J436B, J436C, J436D; J437A, J437B, J437C, J437D; Exp. J436 (2017-03); J437 (2017-03)

    Distribution

    Domestic: MN, CA, OH, IL, FL, MA, WI, VA Foreign: None DOD/VA: None

    Quantity

    880 units