Medical device recalls Moderate risk

Tactical Medical Solutions, Inc. recalls BLAST Bandage, sterile.

Recall date
April 17, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2538-2018
FDA classification
Class II
Brand / firm
Tactical Medical Solutions, Inc.
Sold / distributed
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, Unit…

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

BLAST Bandage, sterile.

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