CDI¿ H/S Cuvette The intended use for the CDI¿ H IS Cuvette is as… — Class III medical device recall Z-0001-2017
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2016-10-12, distributed nationwide. Terumo Cardiovascular Systems (Terumo CVS) has received complaints of the CDI System 500 monitor displaying th
| Recall number | Z-0001-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Terumo Cardiovascular Systems Corporation, Elkton, MD, United States |
| Recall initiated | 2015-12-11 |
| Classified | 2016-10-03 |
| Reported by FDA | 2016-10-12 |
| Terminated | 2016-10-26 |
| Distributed | Nationwide (US) |
| Quantity | 140,000 units |
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.
Reason for recall
Terumo Cardiovascular Systems (Terumo CVS) has received complaints of the CDI System 500 monitor displaying the 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 this situation, blood parameter values for HCT, Hgb, and SO2 do not display.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0001-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.