Agency classClass IIOur severity:Severe FDA (Drugs)·D-0178-2017·Announced 2016-12-14

North American Rescue Recalls Advance Trauma Kits Due to Sterility Concerns

North American Rescue LLC is recalling Advance Trauma Kits because the manufacturer has concerns regarding the sterility of the eye wash irrigating 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 recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric. The hazard involves a lack of assurance of sterility in a medical product, which poses a risk of serious temporary or medically reversible health consequences.

Plain-English summary

North American Rescue LLC is recalling specific lots of the Advance Trauma Kit. The recall is due to concerns raised by the manufacturer regarding the sterility of the eye wash irrigating solution contained within the kits.

The affected products are distributed nationwide as well as in Australia and Switzerland. Specific part numbers and lot numbers are listed in the recall documentation, including part numbers 85-0742, 85-0746, 85-0745, 85-0639, 85-0744, and 85-0741.

Consumers should check their Advance Trauma Kits against the specific part and lot numbers provided in the official recall notice. If the product matches the recalled lots, consumers should stop using the eye wash solution and contact the manufacturer for instructions on return or replacement.

The recalled product

Product: Advance Trauma Kit - Product Code 85-0742, 85-0746, 85-0745, 85-0639, 85-0744, 85-0744, 85-0741, North American Rescue
Manufacturer: North American Rescue LLC.
Category: Medical Device — Trauma Kits
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 # 85-0742 Kit Lot # 85-0742071816
Kit Part # 85-0748 Kit Lot # 85-0746061016
Kit Part # 85-0745 - Kit Lot # 85-0745042516
Kit Part # 85-0639 - Kit Lot # 85-0639080516
85-0639060116
85-0639061016
85-0639071416
85-0639072116
85-0639050316
85-0639050416
85-0639051316
85-0639082216
85-0639090116
85-0639090716
85-0639080116
85-0639091316
Kit Part # 85-0744 - Kit Lot # 85-0744072516
85-0744060916
85-0744052516
Kit Part # 85-0741- Kit Lot # 85-0741071416

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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