Medical device recalls Moderate risk

Steris Corporation recalls AMSCO¿ Warming Cabinet. Manufactured by: STERIS Corporation To raise the temperature of blankets, linens and sterile su…

Recall date
November 20, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0603-2016
FDA classification
Class II
Brand / firm
Steris Corporation
Sold / distributed
Worldwide Distribution: US (nationwide) and countries of: Australia, Austria, Bahrain, Canada, China, Colombia, Costa Rica, France, Hong Kong, India, Indonesia, Israel, Kuwait, Lebanon, Mexico, Panama, Peru, Republic of Korea, Russian Federation, Saudi Arabia, Singapore, Spain, Taiwan, Thailand, Tu…

Why it was recalled

The firm discovered that information printed on the quick reference magnet is incorrect; specifically, Fahrenheit to Celsius temperature conversions and the default Warming Cabinet temperature.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

AMSCO¿ Warming Cabinet. Manufactured by: STERIS Corporation To raise the temperature of blankets, linens and sterile surgical IV/irrigation solutions to an acceptable level for various surgical, obstetrical, emergency, critical care and other healthcare applications.

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