FDA Enforcement
Class II
Terminated
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.
Recall: Z-1337-2019
·
Reported May 22, 2019
Enforcement
- Recall Number
- Z-1337-2019
- Event ID
- 82630
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Terumo Cardiovascular Systems Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 22, 2019
- Initiation Date
- April 18, 2019
- Classification Date
- May 15, 2019
- Termination Date
- May 20, 2020
- Address
- 6200 Jackson Rd, Ann Arbor, MI, 48103-9586, United States
Description
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.
Reason
The gas flow rate output of the EPGS may be inaccurate due to a defect in the internal flowmeter.
Code Info
All
Distribution
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.
Quantity
1258