BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1481-2015 · Initiated April 7, 2015

    Recall

    Recall Number
    Z-1481-2015
    Event Number
    70948
    Firm
    Catheter Research, Inc
    FEI Number
    3008998256
    Product Code
    HGS
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    April 7, 2015
    Posted
    April 21, 2015
    Terminated
    July 17, 2015
    Address
    5610 W 82nd St, Indianapolis, IN, 46278-1300

    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.

    Action

    Catheter Research, Inc. (CRI) has initiated a voluntary medical device removal of HSG Tray/ 5F HS Catheter Combo, and issued letters to customer son 04/07/2015 by e-mail and certified mail. Customers are asked to inspect their inventory and return recalled devices to CRI for replacement. If the devices were further distributed CRI requested customers provide notice of the recall. Customers may contact Babacar Diouf, VP of RA and QS, at (317) 872-0074 ext. 3512.

    Distribution

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

    Quantity

    880 units