Agency classClass IIOur severity:High FDA (Drugs)·D-0176-2017·Announced 2016-12-14

North American Rescue Recalls Range Trauma Kits Due to Sterility Concerns

North American Rescue is recalling specific Range Trauma Kits because the manufacturer has concerns about the sterility of the included 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 3/5 (High).

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 involves a medical device where sterility assurance is compromised, creating a risk of infection or harm, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

North American Rescue LLC is recalling specific units of the Range Trauma Kit ORG (Product Codes 80-0213, 80-0299, and 80-0298). The recall is due to a lack of assurance of sterility regarding the eye wash irrigating solution contained within the kits.

The affected products were distributed nationwide, as well as in Australia and Switzerland. The recall covers specific kit lot numbers associated with the three product codes listed in the official notice.

Consumers should check their Range Trauma Kits for the specific part and lot numbers listed in the recall documentation. If a kit matches the affected codes, consumers should stop using the eye wash solution and contact North American Rescue for instructions on how to proceed.

The recalled product

Product: Range Trauma Kit ORG - Product Code 80-0213, 80-0299, 80-0298, 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 (20)

Kit Part # 80-0213 - Kit Lot # 80-0213080816W
80-0213071316W
80-0213041816W
80-0213051716W
80-0213050516W
80-0213050916W
80-0213081116W
80-0213081716W
80-0213082516W
80-0213090216W
80-0213090916W
80-0213070716W
80-0213080316W
80-0213080116W
80-0213072716W
Kit Part # 80-0299 - Kit Lot # 80-0299080916W
80-0299071116W
80-0299060116W
80-0299051916W
80-0299081716W

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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