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Recall Observatory FDA recall evidence

Device product

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.

Z-0603-2016

November 20, 2015

Class II

Product summary

Firm
Steris Corporation
Event
Event 72825
Status
Terminated
Classification
Class II
Quantity
2,319 units
Official record key
device-enforcement:Z-0603-2016

Official wording

Reason: 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.

Code information: Serial #'s: 0428014026 - 0432115014

Distribution pattern: 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, Turkey, Uganda, United Arab Emirates, Viet Nam & Virgin Islands.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.