Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1867-2024 — 2008T BlueStar Hemodialysis Machine, Model 191124 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.

U.S. FDA — Device Enforcement · United States · 2024-04-17 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1867-2024
Date of alert
2024-04-17
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Fresenius Medical Care Holdings, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00840861102082
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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