Class 2 Device Recall BLAST Bandage

• Date Initiated by Firm: April 17, 2018
• Create Date: July 25, 2018
• Recall Status: Terminated on July 22, 2020
• Recall Number: Z-2538-2018
• Recall Event ID: 80157
• Product Classification: Bandage, elastic - Product Code FQM
• Product: BLAST Bandage, sterile.
• Code Information: Lot 0617
• FEI Number: 3005853033
• Recalling Firm/ Manufacturer: Tactical Medical Solutions, Inc.; 1250 Harris Bridge Rd; Anderson SC 29621-3409
• For Additional Information Contact: 864-224-0081
• Manufacturer Reason for Recall: Blast Bandages (part# BLAST) with Lot# 0617 were not terminally sterilized.
• FDA Determined Cause: Mixed-up of materials/components
• 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.
• Quantity in Commerce: 1,097 units
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.