The Recall Desk
HighFDA (Devices)·Z-1337-2019·Announced 2019-05-22

Terumo Electronic Patient Gas System Recalled for Inaccurate Gas Flow Rate

Terumo is recalling 1,258 Electronic Patient Gas Systems because a flowmeter defect may cause inaccurate gas flow rate output.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a defect in a medical device that controls gas flow rates, which is a risk-of-harm product where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Terumo Cardiovascular Systems Corporation is recalling 1,258 units of the Terumo Advanced Perfusion System 1 Electronic Patient Gas System (Catalog # 801188, UDI 00886799000588). The recall is due to a defect in the internal flowmeter that may cause the gas flow rate output to be inaccurate.

The affected devices are distributed worldwide, including in the United States (nationwide) and in Australia, Belgium, Canada, Chile, Hong Kong, Indonesia, Japan, Mexico, the Philippines, Singapore, South Korea, Taiwan, Thailand, and the United Arab Emirates. The electronic gas blender is used to provide control and monitoring of the gas flow rate and oxygen content of the gas input to the oxygenator in the perfusion circuit.

Healthcare providers and facilities should contact Terumo Cardiovascular Systems Corporation for instructions on how to return the affected devices. The recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

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
Terumo Cardiovascular Systems Corporation
Category
Medical Device — Perfusion Systems
Hazard
Affected units
1,258

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

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Distribution

Distributed nationwide across the United States.

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