BEUDAMED
    FDA Enforcement Class II Terminated

    Dressing M/U XL, P/N 02344 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied in a sterile environment. Breg has determined that a small percentage (approximately 0.22%) of these products may have been sent with unsealed pouches by the contract manufacturer. Customers will be contacted and instructed to inspect their inventory for any product with unsealed pouches and discard them.

    Recall: Z-1902-2017 · Reported May 10, 2017

    Enforcement

    Recall Number
    Z-1902-2017
    Event ID
    76994
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Breg Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 10, 2017
    Initiation Date
    March 30, 2017
    Classification Date
    May 1, 2017
    Termination Date
    June 23, 2017
    Address
    2885 Loker Ave E, Carlsbad, CA, 92010-6626, United States

    Description

    Dressing M/U XL, P/N 02344 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied in a sterile environment. Breg has determined that a small percentage (approximately 0.22%) of these products may have been sent with unsealed pouches by the contract manufacturer. Customers will be contacted and instructed to inspect their inventory for any product with unsealed pouches and discard them.

    Reason

    They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.

    Code Info

    D163474, D163544

    Distribution

    US Nationwide Distribution

    Quantity

    2,609 units total