medical Class II Updated 2025-04-09

Terumo Cardiovascular Systems Corporation recalls Terumo CDI OneView Monitoring System Hematocrit / Oxygen Sat

Recalled Product

Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754

Hazard / Issue

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.

Issued by

FDA

Affected States: IL, TX, NY, MI, FL, NV
Lot/Code Info: UDI/DI 00886799001882, Serial Number range: H0050095-H0050110, H0050112-H0050116, H0050118-H0050124, H0050126, H0050131-H0050134, H0050136, H0050140-H0050142
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