BEUDAMED
    FDA Enforcement Class II Terminated

    3M(TM) Surgical Clipper by Remington(R) REF 9602 The 3M Surgical Clipper Classic, 9602, is intended to remove body hair and head hair from patients in preparation for any medical procedure requiring hair removal.

    Recall: Z-0791-2019 · Reported February 6, 2019

    Enforcement

    Recall Number
    Z-0791-2019
    Event ID
    81933
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    3M Company - Health Care Business
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 6, 2019
    Initiation Date
    January 14, 2019
    Classification Date
    January 30, 2019
    Termination Date
    February 11, 2021
    Address
    3m Center 2510 Conway Ave , B# 275-5-W-6, N/A, Saint Paul, MN, 55144-0001, United States

    Description

    3M(TM) Surgical Clipper by Remington(R) REF 9602 The 3M Surgical Clipper Classic, 9602, is intended to remove body hair and head hair from patients in preparation for any medical procedure requiring hair removal.

    Reason

    3M has recently received reports involving the 3MTM Surgical Clipper by Remington¿, Model 9602, overheating in mobile/field EMS situations while charging from a modified sine wave power inverter.

    Code Info

    all lots

    Distribution

    US Distribution and countries Brazil and Canada.

    Quantity

    19,860 units