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GranuFlo 0FD3251-3BRecalls & reported problems

Fresenius Medical Care Renal Therapies Group, LLC · GranuFlo Dry Acid Concentrate for Bicarbonate Dialysis · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
1
Deaths reported
1
Injuries reported
0
Recalls naming it
2

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840861101597), received between Jun 26, 2017 and Jun 26, 2017 — classified as 1 death.

2 FDA recall records name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Jul 14, 2026Open, Classified

    Complaints of blue-green discoloration in product

    Z-3091-2026 · Root cause: Material/Component Contamination · FDA record ↗

  2. Apr 28, 2021Terminated

    Exposed to freezing temperatures due to refrigerated truck malfunctions

    Z-2084-2021 · Root cause: Environmental control · FDA record ↗

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Cardiac Arrest1
  • Death1
  • Loss of consciousness1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • DeathJun 26, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A CLINIC MANAGER AT A USER FACILITY REPORTED THAT DURING A HEMODIALYSIS (HD) TREATMENT ON (B)(6) 2017, APPROXIMATELY 7 MINUTES AFTER THE INITIATION OF TREATMENT, THE PATIENT LOST CONSCIOUSNESS AND BECAME UNRESPONSIVE. CARDIOPULMONARY RESUSCITATION (CPR) EFFORTS WERE INITIATED AND THE FACILITY CALLED EMERGENCY MEDICAL SERVICES (EMS). EMS PERSONNEL TRANSFERRED THE PATIENT TO EMERGENCY CARE AT A MEDICAL CENTER, WHO LATER NOTIFIED THE FACILITY OF THE PATIENT¿S DEATH. FOLLOW-UP INFORMATION REVEALED THAT THE PATIENT HAD INITIALLY BEEN ADMITTED TO THE HOSPITAL ON (B)(6) 2017 FOR AGGRESSIVE WOUND TREATMENT OF THE LEFT FOOT AND HAD BEEN PREPPED FOR HD THERAPY FOR AGGRESSIVE VOLUME REMOVAL AND UREMIC TOXIN REMOVAL. PRIOR TO THE HOSPITALIZATION, THE PATIENT HAD BEEN AT A REHABILITATION CENTER FOR ALMOST A MONTH FOLLOWING A RIGHT HIP FRACTURE WITH SURGICAL REPAIR. HOWEVER, THE PATIENT HAD WORSENING ANASARCA, HYPOXEMIA, DYSPNEA ON EXERTION REQUIRING SUPPLEMENTAL OXYGEN, AND WEAKNESS LEADING TO THE HOSPITALIZATION OF (B)(6) 2017. DURING THE HOSPITALIZATION, THE PATIENT HAD WEAKNESS, FATIGUE, SHORTNESS OF BREATH, DYSPNEA ON EXERTION, ORTHOPNEA, FOAMY URINE, 4+ EDEMA (LEFT GREATER THEN RIGHT), WEE

    Patient problems: Cardiac Arrest; Death; Loss of consciousness

    MAUDE report 6667976 ↗

Other DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) devices

All DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.