Terumo CDI 101 Hematocrit Monitor Recalled for Inaccurate Readings
Terumo is recalling 622 CDI 101 Hematocrit/Oxygen Saturation Monitoring Systems because software errors cause inaccurate readings of blood and oxygen levels.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a defect that leads to inaccurate readings of critical physiological parameters. This poses a risk of harm to patients due to potential misdiagnosis or treatment errors, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 622 units of the CDI 101 Hematocrit/Oxygen Saturation Monitoring System. The device is used to monitor blood oxygen saturation, hematocrit, and hemoglobin levels. The recall is due to software that contains unused accuracy correction factors for slope and offset in the hematocrit and saturation calculations. As a result, the accuracy on any cuvette size did not meet the required specifications.
The affected units were distributed worldwide. The recall includes specific catalog number 101 and a defined range of serial numbers. No specific dates or geographic locations beyond worldwide distribution are provided in the source text.
Consumers and healthcare facilities should check their inventory for the affected serial numbers. If a unit is found, it should be removed from service and returned to Terumo Cardiovascular Systems Corporation for repair or replacement.
The recalled product
- Product
- Terumo CDI 101 Hematocrit/Oxygen Saturation Monitoring System. Monitors blood/oxygen saturation, hematocrit and hemoglobin levels.
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Affected units
- 622
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 (20)
- Catalog number: 101 and Serial Numbers: 0503
- 1000
- 1017
- 1070
- 1071
- 1073
- 1074
- 1076
- 1077
- 1080
- 1082
- 1083
- 1107-1110
- 1115-1117
- 1124
- 1126-1134
- 1136
- 1137
- 1139-1146
- 1148-1152
Distribution
Distribution scope not specified by the agency.
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