The Recall Desk
HighFDA (Devices)·Z-3018-2020·Announced 2020-10-07

North American Rescue Recalls Emergency Trauma Dressings Due to Sterility Concerns

North American Rescue LLC is recalling 4 In. Flat Responder Emergency Trauma Dressings because they may lack sterility assurance. The affected dressings are packaged in various first aid and trauma kits.

What this means for you

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 is classified as FDA Class II, and the hazard involves a lack of sterility assurance in a medical device used for trauma care, which poses a risk of harm without reported injuries.

Plain-English summary

North American Rescue LLC is recalling 4 In. Flat Responder Emergency Trauma Dressings, part number 30-0171. The recall is due to a lack of sterility assurance for these medical devices. The affected dressings are packaged in numerous first aid and trauma kits, including M-FAK Mini First Aid Kits, Trauma and First Aid Kits, and various individual first aid kits.

The recall covers 11,404 units distributed nationwide in the United States. The specific lot numbers for the dressings are TSD3819 and TSD0320. These dressings are contained in kits with specific Kit Product Codes and Kit Lot Numbers, which are detailed in the official recall notice.

Consumers should check their first aid kits for the affected part number and lot numbers. If the product is found, it should be returned to the point of purchase or disposed of according to local regulations. No specific consumer action instructions beyond the recall are provided in the source text.

The recalled product

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
Manufacturer
North American Rescue LLC.
Category
Medical Device — First Aid / Trauma Dressing
Hazard
Affected units
11,404

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 (20)

  • Lot numbers: TSD3819 and TSD0320
  • Kit Lot Number :80-0890032420 b) Kit Product Code: 80-0891
  • Kit Lot Number: 80-0891032520
  • 80-0891032620 80-0891032720
  • 80-0891040620
  • 80-0891042020
  • 80-0891050420
  • 80-0891050620
  • 80-0891051120
  • 80-0891051920
  • 80-0891052120
  • 80-0891052220
  • 80-0891072920 c) Kit Product Code: 80-0892
  • Kit Lot Number: 80-0892042720
  • 80-0892052020 d) Kit Product Code: 80-0913
  • Kit Lot Number: 80-0913031320
  • 80-0913032020 80-0913032420
  • 80-0913032620
  • 80-0913042120
  • 80-0913042820

Distribution

Distributed nationwide across the United States.

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