Amphibious Trauma Kit - Product Code recalled over sterility concerns
- Recall date
- September 27, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- North American Rescue LLC. recalls Amphibious Trauma Kit - Product Code 85-0639, North American Rescue
- Recall number
- D-0180-2017
- FDA classification
- Class II
- Brand / firm
- North American Rescue LLC.
- Sold / distributed
- Nationwide, Australia & Switzerland
Why it was recalled
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Amphibious Trauma Kit - Product Code 85-0639, North American Rescue
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