North American Rescue Recalls Range Trauma Kits Due to Sterility Concerns
North American Rescue is recalling specific Range Trauma Kits because the manufacturer has concerns about the sterility of the included eye wash solution.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where sterility assurance is compromised, creating a risk of infection or harm, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
North American Rescue LLC is recalling specific units of the Range Trauma Kit ORG (Product Codes 80-0213, 80-0299, and 80-0298). The recall is due to a lack of assurance of sterility regarding the eye wash irrigating solution contained within the kits.
The affected products were distributed nationwide, as well as in Australia and Switzerland. The recall covers specific kit lot numbers associated with the three product codes listed in the official notice.
Consumers should check their Range Trauma Kits for the specific part and lot numbers listed in the recall documentation. If a kit matches the affected codes, consumers should stop using the eye wash solution and contact North American Rescue for instructions on how to proceed.
The recalled product
- Product
- Range Trauma Kit ORG - Product Code 80-0213, 80-0299, 80-0298, North American Rescue
- Manufacturer
- North American Rescue LLC.
- Category
- Medical Device — Trauma Kit
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 # 80-0213 - Kit Lot # 80-0213080816W
- 80-0213071316W
- 80-0213041816W
- 80-0213051716W
- 80-0213050516W
- 80-0213050916W
- 80-0213081116W
- 80-0213081716W
- 80-0213082516W
- 80-0213090216W
- 80-0213090916W
- 80-0213070716W
- 80-0213080316W
- 80-0213080116W
- 80-0213072716W
- Kit Part # 80-0299 - Kit Lot # 80-0299080916W
- 80-0299071116W
- 80-0299060116W
- 80-0299051916W
- 80-0299081716W
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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