Terumo CDI H/S Cuvette Recall Due to Connection Error
Terumo is recalling CDI H/S Cuvettes because they may fail to connect to the probe, causing the monitor to display an error and preventing blood parameter display.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The agency classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The issue is a functional error preventing data display rather than a direct physical hazard.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling approximately 140,000 units of CDI H/S Cuvettes. These medical devices are intended for use with a CDI monitor during cardiopulmonary bypass procedures to continuously monitor blood hematocrit and oxygen saturation. The recall covers units distributed nationwide in the United States and worldwide.
The recall was initiated after the company received complaints that the CDI System 500 monitor displays an "H/S DISCONNECT AT CUVETTE" error message when the CDI H/S Cuvette does not make a proper connection to the CDI H/S Probe. In these instances, blood parameter values for hematocrit (HCT), hemoglobin (Hgb), and oxygen saturation (SO2) do not display on the monitor.
Healthcare facilities should stop using the affected CDI H/S Cuvettes and contact Terumo Cardiovascular Systems Corporation for further instructions on the recall.
The recalled product
- Product
- CDI¿ H/S Cuvette The intended use for the CDI¿ H IS Cuvette is as follows: The CDI¿ H/S Cuvettes are intended for use with a CDI monitor during cardiopulmonary bypass procedures when continuous monitoring of blood hematocrit and oxygen saturation is desired.
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Affected units
- 140,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- 6912
- 6913 6914
- 6932
- 6933 6934
- 6922
- 6923 6924
- CV-6912
- CV-6913
- CV-6914 Cardiovascular Procedure Kits- Various
Distribution
Distributed nationwide across the United States.
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