CDI Blood Parameter Monitoring System 500 with Arterial and Venous… — Class II medical device recall Z-1732-2013
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2013-07-24, distributed nationwide. Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains unu
| Recall number | Z-1732-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Terumo Cardiovascular Systems Corporation, Ann Arbor, MI, United States |
| Recall initiated | 2013-02-27 |
| Classified | 2013-07-13 |
| Reported by FDA | 2013-07-24 |
| Terminated | 2016-02-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, CA, HK, JO, JP, KR, MX, MY, PH, SG, TH, TW |
| Reason classes | software |
| Serial numbers | 0024, 0033, 0040, 0051, 1192, 1193, 1355, 1356, 1420, 1423, 1464, 1465, 1467, 1468, 1483, 1504, 1521-1524, 1526, 1527, 1529, 1530, 1602-1604, 1606, 1662, 2023 and 13 more |
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 temperature are desired.
Reason for recall
Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains unused (turned off) accuracy correction factors for slope (gain) and offset (bias) for Hematocrit/Saturation calculations.
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-1732-2013. 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.