North American Rescue Recalls USCG Boat Response Kits Due to Sterility Concerns
North American Rescue LLC is recalling USCG Boat Response Kits because the manufacturer has concerns about 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 agency classification is FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the risk associated with non-sterile medical irrigation solutions.
Plain-English summary
North American Rescue LLC is voluntarily recalling the USCG Boat Response Kit, Product Code 80-0353. The recall is due to a lack of assurance of sterility regarding the eye wash irrigating solution included in the kit.
The affected product is identified by Kit Part # 80-0353 and Kit Lot # 80-0353051916. The recall covers products distributed nationwide, as well as in Australia and Switzerland.
Consumers who have this product should stop using it and contact North American Rescue LLC for further instructions.
The recalled product
- Product
- USCG Boat Response Kit - Product Code 80-0353, North American Rescue
- Manufacturer
- North American Rescue LLC.
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 (1)
- Kit Part # 80-0353 - Kit Lot # 80-0353051916
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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