Terumo Advanced Perfusion System 1 Electronic Patient recall
Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog # 801188, UDI 00886799000588 The electronic gas blender provides control and…
Why was Terumo Advanced Perfusion System 1 Electronic Patient recalled?
The gas flow rate output of the EPGS may be inaccurate due to a defect in the internal flowmeter.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All
- Product
- Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog # 801188, UDI 00886799000588 The electronic gas blender provides control and…
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Quantity
- 1258
- 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.
- Recall date
- May 22, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)