Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
FDA Recall #Z-1492-2025 — Class II — March 3, 2025
Product Description
Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
Reason for Recall
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.
Recalling Firm
Terumo Cardiovascular Systems Corporation — Ann Arbor, MI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
37 units
Distribution
US: IL, TX, NY, MI, FL, NV, and Australia, New Zealand
Code Information
UDI/DI 00886799001882, Serial Number range: H0050095-H0050110, H0050112-H0050116, H0050118-H0050124, H0050126, H0050131-H0050134, H0050136, H0050140-H0050142
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated