Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
Summary
The FDA issued a Class II for Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catal by Terumo Cardiovascular Systems Corporation. Reason: During some clinical cases, it has been observed that the SO2 value may periodically appear as dashes on the Touchscreen Display indicating unavaila.
Details
Source
Device Recall
External ID
Z-1492-2025
Action Date
2025-04-09
Status
Ongoing
Category
device
Product Description
Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
Lot/Code Info: UDI/DI 00886799001882, Serial Number range: H0050095-H0050110, H0050112-H0050116, H0050118-H0050124, H0050126, H0050131-H0050134, H0050136, H0050140-H0050142
Quantity Affected: 37 units
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.
Distribution
US: IL, TX, NY, MI, FL, NV, and Australia, New Zealand
Type: Voluntary: Firm initiated
Recall Initiated: 2025-03-03
Company
Ann Arbor, MI
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 182 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Terumo Cardiovascular Systems Corporation has 10 FDA actions in our database, including 7 recalls and 3 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Terumo Cardiovascular Systems Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Terumo Cardiovascular Systems Corporation have FDA actions?
Terumo Cardiovascular Systems Corporation has 10 FDA actions in our database, including 7 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1492-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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