BEUDAMED
    FDA Enforcement Class II Ongoing

    TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine tissue removal. Model Number: 7209808

    Recall: Z-1467-2022 · Reported August 3, 2022

    Enforcement

    Recall Number
    Z-1467-2022
    Event ID
    90519
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Covidien Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 3, 2022
    Initiation Date
    June 7, 2022
    Classification Date
    July 26, 2022
    Address
    15 Hampshire St, Mansfield, MA, 02048-1113, United States

    Description

    TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine tissue removal. Model Number: 7209808

    Reason

    Electrical component failure within the control unit. The observed failure mode is a loss of function of the device when used with handpiece and foot switch.

    Code Info

    UDI-Device Identifier (GTIN/UPN) 10884521749931 Serial Number: YF1120, YF1126, YF1127, YF1128, YF1129, YF1130, YF1131, YF1133, YF1134, YF1135, YF1137, YF1138, YF1139, YF1140, YF1141, YF1142, YF1150, YF1152, YF1154, YF1156, YF1157, YF1158, YF1161, YF1163, YF1166, YF1167, YF1168, YF1169, YF1172, YF1175, YF1176, YF1177, YF1182

    Distribution

    AZ CA CO IL KS MA MI MN MO NY OK PA TN TX TX WA Foreign: United Kingdom Ireland Netherlands Reunion Spain

    Quantity

    33 units