FDA (Drugs) recall action 75415
The FDA (Drugs) publishes a recall like this one as 9 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 9 pages.
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
The agency’s own wording, quoted from the enforcement report.
North American Rescue is recalling specific Range Trauma Kits because the manufacturer has concerns about the sterility of the included eye wash solution.
North American Rescue LLC is recalling Aid Backpack Kits because the manufacturer has concerns about the sterility of the eye wash irrigating solution.
North American Rescue LLC is recalling Advance Trauma Kits because the manufacturer has concerns regarding the sterility of the eye wash irrigating solution.
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.
North American Rescue LLC is recalling Mini Resupply Trauma Kits because the manufacturer has concerns about the sterility of the included eye wash solution.
North American Rescue LLC is recalling USCG Boat Response Kits because the manufacturer has concerns about the sterility of the eye wash irrigating solution.
North American Rescue LLC is recalling Range Trauma Kits because the manufacturer has concerns about the sterility of the eye wash solution.
North American Rescue LLC is recalling Range Trauma Kit Hardcases because the manufacturer has concerns about the sterility of the eye wash irrigating solution included in the kits.
North American Rescue is recalling Amphibious Trauma Kits because the manufacturer has concerns about the sterility of the eye wash solution.