Terumo CDI OneView Monitoring System Hematocrit recall
Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
Why was Terumo CDI OneView Monitoring System Hematocrit recalled?
During some clinical cases, it has been observed that the SO2 value may periodically appear as dashes on the Touchscreen Display indicating unavailable data. In these cases, a yellow low-limit alarm will also be triggered to the user, due to the dashed-out value.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
UDI/DI 00886799001882, Serial Number range: H0050095-H0050110, H0050112-H0050116, H0050118-H0050124, H0050126, H0050131-H0050134, H0050136, H0050140-H0050142
- Product
- Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Quantity
- 37 units
- Distribution
- US: IL, TX, NY, MI, FL, NV, and Australia, New Zealand
- Recall date
- April 9, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)