BEUDAMED
    FDA Enforcement Class II Terminated

    Thermacare HEATWRAPS JOINT PAIN THERAPY, 8 HEATWRAPS; MUSCLE PAIN THERAPY, 3 HEATWRAPS a) UPC 0573301311 b) UPC 0573301311 Product Usage: Provides heat therapy for temporary relief of minor muscular and joint aches and pains associated with overexertion, sprains, and arthritis.

    Recall: Z-0556-2019 · Reported December 12, 2018

    Enforcement

    Recall Number
    Z-0556-2019
    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 JOINT PAIN THERAPY, 8 HEATWRAPS; MUSCLE PAIN THERAPY, 3 HEATWRAPS a) UPC 0573301311 b) UPC 0573301311 Product Usage: Provides heat therapy for temporary relief of minor muscular and joint aches and pains associated with overexertion, sprains, and arthritis.

    Reason

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

    Code Info

    a) UPC 0573301311 Bundled Lot Number 8054HA Carton/Pouch Number T26686 b) UPC 0573301311 Bundled Lot Number 8054HB Carton/Pouch Number T26686

    Distribution

    US Nationwide Distribution and PR

    Quantity

    4956 units