North American Rescue Recalls Amphibious Trauma Kits Due to Sterility Concerns
North American Rescue is recalling Amphibious Trauma Kits because the manufacturer has concerns about the sterility of the eye wash solution.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II. Per the rubric, FDA Class II recalls are categorized as Severe (Score 4), particularly when involving sterility issues in medical products where hospitalization or significant injury risks are implied by the defect type.
Plain-English summary
North American Rescue LLC is recalling Amphibious Trauma Kits (Product Code 85-0639) due to a lack of assurance of sterility. The recall is triggered by concerns raised by the manufacturer regarding the sterility of the eye wash irrigating solution included in the kits.
The affected products were distributed nationwide in the United States, as well as in Australia and Switzerland. Specific lot numbers for the recalled kits include 85-0639080516, 85-0639060116, 85-0639061016, 85-0639071416, 85-0639072116, 85-0639050316, 85-0639050416, 85-0639051316, 85-0639082216, 85-0639090116, and 85-0639091316.
Consumers should check their Amphibious Trauma Kits for the product code 85-0639 and the listed lot numbers. If the product matches the recall description, consumers should stop using it and contact North American Rescue LLC for further instructions.
The recalled product
- Product
- Amphibious Trauma Kit - Product Code 85-0639, North American Rescue
- Manufacturer
- North American Rescue LLC.
- Category
- Medical Device — Trauma Kits
- 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 (11)
- 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
- 85-0639091316
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.
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