BEUDAMED
    FDA Enforcement Class II Terminated

    BLAST Bandage, sterile.

    Recall: Z-2538-2018 · Reported August 1, 2018

    Enforcement

    Recall Number
    Z-2538-2018
    Event ID
    80157
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Tactical Medical Solutions, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    August 1, 2018
    Initiation Date
    April 17, 2018
    Classification Date
    July 25, 2018
    Termination Date
    July 22, 2020
    Address
    1250 Harris Bridge Rd, N/A, Anderson, SC, 29621-3409, United States

    Description

    BLAST Bandage, sterile.

    Reason

    Blast Bandages (part# BLAST) with Lot# 0617 were not terminally sterilized.

    Code Info

    Lot 0617

    Distribution

    Domestic distribution to AL, AP, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MO, MS, NC, ND, NM, NY, OH, PA, SC, TX, VA, WI. International distribution to Austria, Canada, France, Kenya, Latvia, Netherlands, New Zealand, Poland, Singapore, South Africa, Switzerland, Turkey, United Kingdom.

    Quantity

    1,097 units