The Recall Desk
ModerateFDA (Devices)·Z-2750-2018·Announced 2018-08-22

Terumo CDI Blood Parameter Monitoring System 500 H/SAT Recalled for Self-Test Failures

Terumo is recalling 128 CDI Blood Parameter Monitoring System 500 H/SAT units because a hybrid intensity shift causes the automated Color Chip Test to fail, disabling the H/Sat module.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The source text explicitly states that the issue will not result in device inaccuracy, only a self-test failure that disables a specific module. This aligns with the rubric for moderate severity, as it is a functional defect without reported harm or inaccuracy.

Plain-English summary

Terumo Cardiovascular Systems Corporation is recalling 128 units of the CDI Blood Parameter Monitoring System 500 H/SAT (Part No. 145883). The recall is due to a hybrid intensity shift observed in a subset of the H/Sat population, which results in an increase of Hybrids failing the H/Sat Color Chip Test. This test is an automated self-test that runs when the device is powered on.

The source text explicitly states that this issue will not result in device inaccuracy. The failure of the Color Chip Test only disables the H/Sat module. The affected units were distributed worldwide, including nationwide in the United States and to the Middle East, Latin America, Europe, Japan, Canada, and Mexico.

Consumers and healthcare facilities should check their inventory for the specific serial numbers listed in the recall notice. If a unit is affected, it should be removed from service to prevent the H/Sat module from being disabled during operation.

The recalled product

Product
CDI Blood parameter monitoring system 500 H/SAT, Part No. 145883 Product Usage: The CDI System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and tempera
Manufacturer
Terumo Cardiovascular Systems Corporation
Category
Medical Device — Blood Parameter Monitoring
Hazard
Affected units
128

Distribution

Distributed nationwide across the United States.

The notice also names 23 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Terumo Cardiovascular Systems Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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