CP5 Centrifugal Pump — Class II medical device recall Z-0401-2018
Terminated recall by Sorin Group Deutschland GmbH, reported 2018-01-31. Possibility that the automatic line closure by the Electronic Remote-Controlled (ERC) clamp after detection of
| Recall number | Z-0401-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sorin Group Deutschland GmbH, Munich, N/A, Germany |
| Recall initiated | 2017-10-30 |
| Classified | 2018-01-19 |
| Reported by FDA | 2018-01-31 |
| Terminated | 2024-01-26 |
| Countries outside the US | AT, AU, BE, BH, CA, CH, CN, CO, CZ, DE, DZ, EC, EE, ES, FI, FR, GB, HK, HR, IQ, IT, JO, JP, KW, LT, LU, MA, MY, NL, NO, PA, PE, PL, QA, RS, SA, SE, SG, SK, TN, VN, ZA |
| Quantity | 1,318 units |
| UPC / GTIN / UDI-DI | 04033817900948, 04033817900955, 04033817901006 |
| Model numbers | 60-00-60, 60-01-04, 60-01-35, 60-02-60 |
Product
CP5 Centrifugal Pump, made up of the drive unit, the emergency system and the pump control panel. It used with an Electrical Remote-Controlled (ERC) tubing clamp and a bubble sensor.
Reason for recall
Possibility that the automatic line closure by the Electronic Remote-Controlled (ERC) clamp after detection of an air bubble could take longer than is intended by design in the CP5 system.
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-0401-2018. 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.