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Terminated

BLAST Bandage, sterile.

FDA Recall Z-2538-2018 · Posted None

Recalling FirmTactical Medical Solutions, Inc.
Recall StatusTerminated
Product CodeFQM
Date Initiated2018-04-17
Date Terminated2020-07-22
Product Quantity1,097 units

Reason for Recall

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

Firm 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.

Root Cause

Mixed-up of materials/components

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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