The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0177-2017·Announced 2016-12-14

North American Rescue Recalls Range Trauma Kits Due to Sterility Concerns

North American Rescue LLC is recalling Range Trauma Kits because the manufacturer has concerns about the sterility of the eye wash solution.

The agency’s classification

FDA (Drugs): 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving sterility issues in medical products.

Plain-English summary

North American Rescue LLC is recalling the Range Trauma Kit, Product Code 85-1274. The recall is due to a lack of assurance of sterility regarding the eye wash irrigating solution included in the kit.

The affected products are identified by Kit Part # 85-1274 and Kit Lot # 85-1274072516W. These kits were distributed nationwide in the United States, as well as in Australia and Switzerland.

The U.S. Food and Drug Administration has classified this recall as Class II. Consumers should stop using the affected eye wash solution and contact the manufacturer for further instructions.

The recalled product

Product
Range Trauma Kit - Product Code 85-1274, North American Rescue
Manufacturer
North American Rescue LLC.
Category
Medical Device — First Aid / Trauma Kit
Hazard

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)

  • Kit Part # 85-1274 - Kit Lot # 85-1274072516W

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 9 recalled by North American Rescue LLC. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 9 products in this recall →

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Same manufacturer · North American Rescue LLC.

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Same hazard · sterility

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