Z-1337-2019 Class II Terminated
FDA device recall Z-1337-2019 was initiated by Terumo Cardiovascular Systems Corporation on April 18, 2019 and is designated Class II. Reason for recall: The gas flow rate output of the EPGS may be inaccurate due to a defect in the internal flowmeter. The recall status is terminated (terminated May 20, 2020). Affected quantity: 1258.
Recall Details
- Product Type
- Devices
- Report Date
- May 22, 2019
- Initiation Date
- April 18, 2019
- Termination Date
- May 20, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1258
Product 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 for Recall
The gas flow rate output of the EPGS may be inaccurate due to a defect in the internal flowmeter.
Distribution Pattern
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.
Code Information
All