Reported Apr 9, 2025 · Ongoing
Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
Terumo Cardiovascular Systems Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Terumo Cardiovascular Systems Corporation · 6200 Jackson Rd · Ann Arbor, MI · 48103-9586
Is this the product you have?
- Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
- Lot codes and dates
- UDI/DI 00886799001882
- Serial Number range
H0050095-H0050110H0050112-H0050116H0050118-H0050124H0050126H0050131-H0050134H0050136H0050140-H0050142
- Amount recalled
- 37 units
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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