Agency classClass IIOur severity:Severe FDA (Drugs)·D-0175-2017·Announced 2016-12-14

North American Rescue Recalls Range Trauma Kits Due to Sterility Concerns

North American Rescue LLC is recalling Range Trauma Kit Hardcases because the manufacturer has concerns about the sterility of the eye wash irrigating solution included in the kits.

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 recall is classified as FDA Class II, which corresponds to a Severe severity score (4) according to the rubric, as it involves a potential health risk that may cause temporary or medically reversible harm.

Plain-English summary

North American Rescue LLC is voluntarily recalling specific lots of the Range Trauma Kit Hardcase (Product Code 85-0889). The recall is being conducted due to a lack of assurance of sterility regarding the eye wash irrigating solution contained within the kits.

The affected products were distributed nationwide in the United States, as well as in Australia and Switzerland. The recall covers kits with specific lot numbers, including 85-0889082416, 85-0889071816, and 85-0889071916, among others listed in the official notice.

Consumers who possess these specific kits should stop using the eye wash solution and contact North American Rescue LLC for further instructions on how to return the product or obtain a replacement.

The recalled product

Product: Range Trauma Kit Hardcase - Product Code 85-0889, North American Rescue
Manufacturer: North American Rescue LLC.
Category: Medical Device — Trauma Kit
Hazard: sterility
infection

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 (14)

Kit Part # 85-0889 - Kit Lot # 85-0889082416
85-0889071816
85-0889071916
85-0889071416
85-0889052316
85-0889050416
85-0889042016
85-0889041416
85-0889090616
85-0889090716
85-0889060216
85-0889062216
85-0889080116
85-0889080816

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 →

Same manufacturer · North American Rescue LLC.

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