BEUDAMED
    FDA Enforcement Class II Terminated

    Thermacare HeatWraps Menstrual a) UPC 0573302002 b) UPC 0573302044 Product Usage: Provides heat therapy for temporary relief of minor menstrual cramp pain and associated back aches.

    Recall: Z-0555-2019 · Reported December 12, 2018

    Enforcement

    Recall Number
    Z-0555-2019
    Event ID
    81178
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Pfizer Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 12, 2018
    Initiation Date
    October 2, 2018
    Classification Date
    December 4, 2018
    Termination Date
    August 28, 2023
    Address
    235 E 42nd St, N/A, New York, NY, 10017-5703, United States

    Description

    Thermacare HeatWraps Menstrual a) UPC 0573302002 b) UPC 0573302044 Product Usage: Provides heat therapy for temporary relief of minor menstrual cramp pain and associated back aches.

    Reason

    The firm received complaints of the wrap coming apart and leaking granular material

    Code Info

    a) UPC 0573302002 Carton/Pouch Number T26691 b) UPC 0573302044 Carton/Pouch Number T26693

    Distribution

    US Nationwide Distribution and PR

    Quantity

    293880 units