Reported Oct 7, 2020 · Terminated

4 In. Flat Responder Emergency Trauma Dressing part number 30-0171, packaged in kits labeled as follows: a) M-FAK Mini…

North American Rescue LLC.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: North American Rescue LLC. · 35 Tedwall Ct · Greer, SC · 29650-4791

Is this the product you have?

26 of 26 products

Products covered by this recall
Model / numberProduct as published
80-0890M-FAK Mini First Aid Kit; Kit
80-0891M-FAK Mini First Aid Kit, with Bleeding Control Dressing; Kit
80-0892M-FAK Mini First Aid Kit, Advance; Kit
80-0913M-FAK Mini First Aid Kit, Basic; Kit
80-0914M-FAK Mini First Aid Kit; Kit
80-0947Trauma and First Aid Kit; Kit
80-0948Trauma and First Aid Kit; Kit
80-1047Trauma and First Aid Kit; Kit
80-1048Trauma and First Aid Kit Hard Case, Class B, with Bleeding Control Dressing; Kit
82-0002Micro individual first aid kit; Kit
85-0404Individual Aid Kit; Kit
85-0757KMBR HII Kit; Kit
85-0834Compact Officer Response Emergency Kit; Kit
80-0951Public Access Bleeding Control Twin Pack, Basic; Kit
80-0952Public Access Bleeding Control Twin Pack, Intermediate; Kit
80-0953Public Access Bleeding Control Twin Pack, Advanced BCD; Kit
80-1033Trauma and First Aid Kit; Kit
80-1034Trauma and First Aid Kit Hard Case; Kit
85-1128Tactical Quick Reaction Individual first aid kit; Kit
85-1502M-FAK Kit with S-Rolled Gauze; Kit
Amount recalled
11404 each

Where it was sold

  • Nationwide

Why it was recalled

Lack of sterility assurance of the 30-0171

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 31, 2024 · Data as of Sep 19, 5:31 PM UTC

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