2008T BlueStar Hemodialysis Machine — Class II medical device recall Z-1869-2024
Ongoing recall by Fresenius Medical Care Holdings, Inc., reported 2024-05-29, distributed nationwide. An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period
| Recall number | Z-1869-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Medical Care Holdings, Inc., Waltham, MA, United States |
| Recall initiated | 2024-04-17 |
| Classified | 2024-05-17 |
| Reported by FDA | 2024-05-29 |
| Distributed | Nationwide (US) |
| Quantity | 334 units |
| UPC / GTIN / UDI-DI | 00840861102105 |
| Serial numbers | 1T0S256406, 1T0S260150, 1T0S260151, 1T0S260152, 1T0S260154, 1T0S260155, 1T0S260156, 1T0S260157, 1T0S260158, 1T0S260159, 1T0S260161, 1T0S260162, 1T0S260163, 1T0S260164, 1T0S260165, 1T0S260166, 1T0S260167, 1T0S260169, 1T0S260172, 1T0S260173, 1T0S260174, 1T0S260175, 1T0S260176, 1T0S260177, 1T0S260178 and 309 more |
| Model numbers | 191128, F40015481 |
Product
2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
Reason for recall
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
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-1869-2024. 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.