Drug & medication recalls Moderate risk

USCG Boat Response 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 USCG Boat Response Kit - Product Code 80-0353, North American Rescue
Recall number
D-0183-2017
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

USCG Boat Response Kit - Product Code 80-0353, North American Rescue

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