The Recall Desk
ModerateFDA (Devices)·Z-1732-2013·Announced 2013-07-24

Terumo Recalls CDI 500 Blood Parameter Monitoring Systems

Terumo is recalling CDI 500 Blood Parameter Monitoring Systems because software contains unused accuracy correction factors for hematocrit and saturation calculations.

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 recall is classified as FDA Class II, and the source text describes a software issue involving unused correction factors without reporting any specific injuries, illnesses, or deaths, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Terumo Cardiovascular Systems Corporation is recalling the CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules. The recall involves 3,972 units manufactured since April 26, 2012, which were distributed nationwide in the United States and in several international countries.

The recall was initiated after Terumo discovered through its own testing that the system's software contains unused accuracy correction factors for slope and offset in Hematocrit and Saturation calculations. These factors are currently turned off. The devices are intended for use during cardiopulmonary bypass procedures to monitor blood parameters.

Healthcare facilities and users should contact Terumo Cardiovascular Systems Corporation for further instructions on how to proceed with the recall.

The recalled product

Product
CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperatur
Manufacturer
Terumo Cardiovascular Systems Corporation
Category
Medical Device — Monitoring Systems
Hazard

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: 500AV* and serial numbers: 0024
  • 0033
  • 0040
  • 0051
  • 1192
  • 1193
  • 1355
  • 1356
  • 1420
  • 1423
  • 1464
  • 1465
  • 1467
  • 1468
  • 1483
  • 1504
  • 1521-1524
  • 1526
  • 1527
  • 1529

Distribution

Distributed nationwide across the United States.

The notice also names 49 states specifically:

Part of a larger recall action

This product is one of 5 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 5 products in this recall →

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Same manufacturer · Terumo Cardiovascular Systems Corporation

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Same hazard · software defect

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