2008T BlueStar Hemodialysis Machine — Class II medical device recall Z-1867-2024
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-1867-2024 |
|---|---|
| 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 | 931 units |
| UPC / GTIN / UDI-DI | 00840861102082 |
| Serial numbers | 0T0S250989, 0T0S251188, 0T0S251191, 0T0S251290, 0T0S251298, 0T0S251300, 0T0S251302, 0T0S251304, 0T0S251306, 0T0S251307, 0T0S251308, 0T0S251309, 0T0S251316, 0T0S251487, 0T0S251488, 0T0S251489, 0T0S251490, 0T0S251492, 0T0S251494, 0T0S251495, 0T0S251496, 0T0S251497, 0T0S251498, 0T0S251499, 0T0S251502 and 475 more |
| Model numbers | 191124, F40015481 |
Product
2008T BlueStar Hemodialysis Machine, Model 191124 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-1867-2024. 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.