Tactical Medical Solutions Recalls Unsterilized BLAST Bandages
Tactical Medical Solutions is recalling 1,097 units of BLAST Bandages, Lot 0617, because they were not terminally sterilized.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device that failed to meet sterilization requirements, creating a risk of infection or harm. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Tactical Medical Solutions, Inc. is recalling 1,097 units of BLAST Bandage, sterile, Lot 0617. The recall was initiated because the affected bandages were not terminally sterilized.
The affected products were distributed domestically to 31 states and the District of Columbia, as well as internationally to 13 countries including Canada, the United Kingdom, and France. The specific states and countries are listed in the official recall notice.
Consumers who have purchased BLAST Bandages with Lot 0617 should stop using them immediately and contact the manufacturer for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- BLAST Bandage, sterile.
- Manufacturer
- Tactical Medical Solutions, Inc.
- Category
- Medical Device — Wound Care
- Affected units
- 1,097
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot 0617
Distribution
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