North American Rescue Recalls Mini Resupply Trauma Kits Due to Sterility Concerns
North American Rescue LLC is recalling Mini Resupply 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 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 classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe).
Plain-English summary
North American Rescue LLC is voluntarily recalling the Mini Resupply Trauma Kit, Product Code 85-0835. The recall is due to a lack of assurance of sterility regarding the eye wash irrigating solution included in the kits.
The affected kits were distributed nationwide, as well as in Australia and Switzerland. Specific lot numbers involved in the recall include 85-0835061016, 85-0835052416, 85-0835051116, 85-0835050216, 85-0835042916, 85-0835072616, and 85-0835072016.
Consumers should check their inventory for these specific lot numbers. If you have an affected kit, you should stop using it and contact North American Rescue LLC for instructions on how to return the product or obtain a refund.
The recalled product
- Product
- Mini Resupply Trauma Kit - Product Code 85-0835, North American Rescue
- Manufacturer
- North American Rescue LLC.
- Category
- Medical Device — Trauma Kit
- 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 (7)
- Kit Part # 85-0835 - Kit Lot # 85-0835061016
- 85-0835052416
- 85-0835051116
- 85-0835050216
- 85-0835042916
- 85-0835072616
- 85-0835072016
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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