Z-2538-2018Class II

BLAST Bandage, sterile

Name: Z-2538-2018 BLAST Bandage, sterile
Creator: Tactical Medical Solutions, Inc.
Published: 2018-04-17
License: https://open.fda.gov/license/

Tacmed Solutions, LLC / initiated 2018-04-17 / Terminated / root cause: sterility

FDA source

Tactical Medical Solutions, Inc. began a recall of BLAST Bandage, sterile on 2018-04-17. FDA classified it as Class II and gives the reason as "Blast Bandages (part# BLAST) with Lot# 0617 were not terminally sterilized". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-2538-2018
Classification: Class II
Status: Terminated
Initiated: 2018-04-17
Posted: 2018-07-25
Terminated: 2020-07-22
Recalling firm: Tacmed Solutions, LLC
Product: BLAST Bandage, sterile.
Product code: FQM Bandage, Elastic
Reason for recall: Blast Bandages (part# BLAST) with Lot# 0617 were not terminally sterilized.
Root cause tag: sterility
FDA root 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.
Product codes and lots: Lot 0617

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2538-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2538-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-01	2018-07-25

Product code FQM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)