# FDA recall Z-3018-2020

> **North American Rescue LLC.** · Class II · device recall initiated 2020-08-21.

## Product

4 In. Flat Responder Emergency Trauma Dressing part number 30-0171, packaged in kits labeled as follows:    a) M-FAK Mini First Aid Kit; Kit Product Code: 80-0890    b) M-FAK Mini First Aid Kit, with Bleeding Control Dressing; Kit Product Code: 80-0891    c) M-FAK Mini First Aid Kit, Advance; Kit Product Code: 80-0892    d) M-FAK Mini First Aid Kit, Basic; Kit Product Code: 80-0913    e) M-FAK Mini First Aid Kit; Kit Product Code: 80-0914    f) Trauma and First Aid Kit; Kit Product Code: 80-0947    g) Trauma and First Aid Kit; Kit Product Code: 80-0948    h) Trauma and First Aid Kit; Kit Product Code: 80-1047    i) Trauma and First Aid Kit Hard Case, Class B, with Bleeding Control Dressing; Kit Product Code: 80-1048    j) Micro individual first aid kit; Kit Product Code: 82-0002    k) Individual Aid Kit; Kit Product Code: 85-0404    l) KMBR HII Kit; Kit Product Code: 85-0757    m) Compact Officer Response Emergency Kit; Kit Product Code: 85-0834    n) Public Access Bleeding Control Twi

## Reason for recall

Lack of sterility  assurance of the 30-0171

## Distribution

US Nationwide distribution

## Key facts

- **Recall number:** Z-3018-2020
- **Recalling firm:** North American Rescue LLC.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-08-21
- **Report date:** 2020-10-07
- **Termination date:** 2024-01-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Greer, SC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3018-2020

## Citation

> AI Analytics. FDA recall Z-3018-2020. Retrieved 2026-07-03 from https://api.ai-analytics.org/recall/Z-3018-2020. Source: US FDA. Licensed CC0.

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