BEUDAMED
    FDA Recall Terminated

    BLAST Bandage, sterile.

    Recall: Z-2538-2018 · Initiated April 17, 2018

    Recall

    Recall Number
    Z-2538-2018
    Event Number
    80157
    Firm
    Tactical Medical Solutions, Inc.
    FEI Number
    3005853033
    Product Code
    FQM
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    April 17, 2018
    Terminated
    July 22, 2020
    Address
    1250 Harris Bridge Rd, Anderson, SC, 29621-3409

    Description

    BLAST Bandage, sterile.

    Reason

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

    Action

    Customers were notified on 04/17/2018 via letter and email. Instructions included to review bandages in inventory for affected lot, contact Tactical Medical to arrange replacement, complete and return the Acknowledgement and Receipt Form.

    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