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Recall Observatory FDA recall evidence

Device product

BLAST Bandage, sterile.

Z-2538-2018

April 17, 2018

Class II

Product summary

Firm
Tactical Medical Solutions, Inc.
Event
Event 80157
Status
Terminated
Classification
Class II
Quantity
1,097 units
Official record key
device-enforcement:Z-2538-2018

Official wording

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

Code information: Lot 0617

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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