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Terumo Cardiovascular Systems Corporation recalls Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog # 801188, UDI 00886799000588 The electronic
Recalled May 22, 2019 · FDA recall Z-1337-2019 · Terumo Cardiovascular Systems
Hazard
The gas flow rate output of the EPGS may be inaccurate due to a defect in the internal flowmeter. · FDA Class II
Units
1258
Sold at
Worldwide Distribution: US (nationwide) and countries of: Australia, Belgium, Canada, Chile, Hong Kong, Indonesia, Japan, Mexico, Philippines, Singapore, South Korea, Taiwan, Thailand, and United Arab Emirates.
Description
The gas flow rate output of the EPGS may be inaccurate due to a defect in the internal flowmeter.
Product
Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog # 801188, UDI 00886799000588 The electronic gas blender provides control and monitoring of the gas flow rate and oxygen content of the gas input to the oxygenator in the perfusion circuit.
Manufacturer(s)
Terumo Cardiovascular Systems Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →