Agency classClass IIOur severity:Severe FDA (Drugs)·D-0179-2017·Announced 2016-12-14

North American Rescue Recalls K-9 Trauma Field Kits Due to Sterility Concerns

North American Rescue LLC is recalling K-9 Trauma Field Kits because the manufacturer has concerns about the sterility of the included 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 source text identifies this as an FDA Class II recall. According to the severity rubric, FDA Class II recalls are classified as Severe (Score 4), particularly when involving sterility issues that could lead to adverse health consequences.

Plain-English summary

North American Rescue LLC is recalling specific lots of the K-9 Trauma Field Kit. The recall involves product codes 80-0211, 80-0304, 80-0209, 80-0210, 80-0300, and 80-0301. The affected products were distributed nationwide in the United States, as well as in Australia and Switzerland.

The recall was initiated due to a lack of assurance of sterility. The manufacturer has identified concerns regarding the sterility of the eye wash irrigating solution contained within the kits. This is an FDA Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers who possess these specific kits should stop using them and contact North American Rescue LLC for instructions on how to return the product or obtain a replacement. The recall is limited to the specific lot numbers listed in the official FDA notice.

The recalled product

Product: K-9 Trauma Field Kit - Product Code 80-0211, 80-0304, 80-0209, 80-0210, 80-0300, 80-0301, North American Rescue
Manufacturer: North American Rescue LLC.
Category: Medical Device — First Aid / 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 # 80-0211 - Kit Lot # 80-0211070616
80-0211051316
80-0211041816
80-0211030216
80-0211072216
80-0210070716
80-0210050416W
80-0210072216
Kit Part # 80-0304 - Kit Lot # 80-0304041916
Kit Part # 80-0209 - Kit Lot # 80-0209082216
80-0209051816
80-0209051616
80-029050316
80-0209041916
80-0209060316
Kit Part # 80-210 Kit Lot # 80-021007076
Kit Part # 80-0300 - Kit Lot # 80-0300081216
80-0300050916
80-0300050316
80-0300041916

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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