Lower risk Medical device recall · FDA · Published August 21, 2020

North American Rescue 4-In. Flat Emergency Trauma Dressing Kits: Lack Sterility Assurance

North American Rescue recalls 4-In. Flat Emergency Trauma Dressing kits (part number 30-0171) due to lack of sterility assurance. Affected kits include various M-FAK Mini and Trauma First Aid Kits with specific product codes and lot numbers listed.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-3018-2020Medical device North American Rescue ›

Lower-risk recall

Lack of sterility assurance of the 30-0171

Take action

Contact the company

Recalling firmNorth American Rescue LLC.35 Tedwall Ct · Greer, SC 29650-4791

✎ GovInfoNow plain-language explainer

North American Rescue is recalling 4-inch flat emergency trauma dressings (part number 30-0171) because they lack proper sterility assurance. This means the dressings might not be clean enough for medical use, potentially leading to infections if used improperly. Read more at govinfonow.com/recall/64446-north-american-rescue-4-in-flat-emergency-trauma-dressing-kits.

Source Summary by GovInfoNow · govinfonow.com/recall/64446-north-american-rescue-4-in-flat-emergency-trauma-dressing-kits · Updated August 19, 2026 · FDA enforcement record: FDA #Z-3018-2020

Cite this page

“North American Rescue 4-In. Flat Emergency Trauma Dressing Kits: Lack Sterility Assurance.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64446-north-american-rescue-4-in-flat-emergency-trauma-dressing-kits. Based on FDA recall #Z-3018-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3018-2020%22&limit=1).

The FDA announced on 2020-08-21 that North American Rescue LLC. is recalling 4 In. Flat Responder Emergency Trauma Dressing part number 30-0171 due to a lack of sterility assurance. The agency issued recall number Z-3018-2020 for the Class II device.

How to tell if you have it

Brand: North American Rescue
Product: 4 In. Flat Responder Emergency Trauma Dressing, part number 30-0171
Lot numbers: TSD3819 and TSD0320
Kit Product Codes: 80-0890, 80-0891, 80-0892, 80-0913, 80-0914, 80-0947, 80-0948, 80-1047, 80-1048, 82-0002, 85-0404, 85-0757, 85-0834, 80-0951, 80-0952, 80-0953, 80-1033, 80-1034, 85-1128, 85-1502, 85-1574, 85-1583, 85-1759, 85-1907, 85-1942, 85-1953, 85-1970, 85-2150, 85-2176, 85-2327, 85-2425, 85-2426, 85-2430, 85-2432, 85-2539, 85-2833, 85-2886, 80-1045, 80-1046, 85-2920, 85-3022, 85-3046, 85-3050, 85-3052, 85-3067, 85-3068, 85-3069, 85-3078, 85-3082, 85-3084, 85-3085
Distribution: US Nationwide

The hazard

The recall addresses a lack of sterility assurance for the 4 In. Flat Responder Emergency Trauma Dressing part number 30-0171, according to the FDA.

Context

GovInfoNow's records show North American Rescue LLC. has 4 other recalls on record since 2016-09-27. Other recent recalls of similar products include Medline Convenience Kits Recall: Sterile Saline Wound Wash May Not Meet Sterility Standards (2026-01-05), Medline Convenience Kits Recall: Calibration Issues May Affect Sterility (2026-01-07) and Medline Convenience Kits: Sterility Risk Due to Calibration Issues (2026-01-07).

How to tell if you have this one

Check for kits labeled as M-FAK Mini or Trauma First Aid Kits with product codes from 80-0890 to 85-3085. The specific lot numbers listed in the recall record indicate which kits are affected.

Brand
North American Rescue
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check for Affected Kits
Look for kits labeled as M-FAK Mini or Trauma First Aid Kits with product codes from 80-0890 to 85-3085 and the listed lot numbers.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 3.4 years after the firm started it.

Aug 21, 2020Firm started the recall
Sep 25, 2020FDA classified it Class II
Oct 7, 2020Published in FDA’s Enforcement Report
Jan 31, 2024FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to do anything?

Yes, check if your kit is affected by looking at the product code and lot number. If it is, you should stop using it and replace it with a certified sterile dressing.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/64446-north-american-rescue-4-in-flat-emergency-trauma-dressing-kits">North American Rescue 4-In. Flat Emergency Trauma Dressing Kits: Lack Sterility Assurance (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-3018-2020 (August 21, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3018-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.