Terumo Recalls CDI Blood Parameter Monitoring System for Inaccurate Readings
Terumo is recalling one CDI Blood Parameter Monitoring System unit in Iowa due to potential inaccuracies in blood gas and hemoglobin measurements.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a medical device with potential for significant injury (infection, inflammatory reaction, respiratory alkalosis) due to inaccurate measurements.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling one unit of the CDI Blood Parameter Monitoring System (Catalog Numbers 145891, 500AVHCT; Serial Number BPM SN B015552, installed into CDI 500 Monitor SN 3535). The recall was initiated because the device shipped without meeting manufacturing acceptance criteria, which creates a potential for inaccuracies in blood gas readings and measurements.
The FDA classifies this as a Class II recall. Inaccurate measurements could lead to clinical risks, including respiratory alkalosis or cerebral vasoconstriction if paCO2 is low, or unnecessary blood transfusions if Hemoglobin and Hematocrit measurements are incorrect. Unnecessary transfusions carry a resulting risk of infection or inflammatory reaction.
The affected unit was distributed to one customer in Iowa. The source text does not specify instructions for consumers or healthcare providers regarding the next steps for this specific recall.
The recalled product
- Product
- CDI Blood Parameter Monitoring System; Catalog Numbers or Part Numbers - 145891, 500AVHCT; Serial Numbers - BPM SN B015552 (installed into CDI 500 Monitor SN 3535)
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Affected units
- 1
Distribution
Distributed in 1 state:
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