MedicaLyte BC+201Recalls & reported problems
Nipro Renal Solutions USA Corporation · Liquid Bicarbonate Concentrate for Hemodialysis · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This MedicaLyte BC+201 is a liquid bicarbonate concentrate used for hemodialysis. The 41 reports mostly describe dark debris, foreign material, or possible mold in the solution, with 1 death and 4 injuries. There is 1 open recall, started in April 2025 because visible foreign matter may be present; reports fell from 41 in the previous 12 months to 0 in the latest 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 41
- Deaths reported
- 1
- Injuries reported
- 4
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00817411022824), received between Feb 26, 2025 and Jun 3, 2025 — classified as 1 death, 4 injuries, 36 malfunctions.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (40 reports).
1 FDA recall record name this device's identifier, 1 still open.
1 other recall cover devices cleared under the same FDA submission (K012547); they may or may not involve this specific model.
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Apr 11, 2025Class IOpen, Classified
Potential for the presence of visible foreign matter.
Z-1730-2025 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Device Contaminated During Manufacture or Shipping40
- Contamination1
Patient problems
- No Clinical Signs, Symptoms or Conditions37
- Insufficient Information3
- Bacteremia1
Recent adverse event reports
The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 3, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
DARK COLORED DEBRIS MOVING AROUND UNOPENED BICARBONATE SOLUTION WHILE PREPARING FOR DIALYSIS TREATMENT. SOLUTION WITH DEBRIS WAS NOT USED FOR PATIENT TREATMENT AND REMAINING SOLUTION FROM THE SAME LOT WAS CHECKED AND NO OTHER BOTTLE WAS FOUND TO HAVE DEBRIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22134120 ↗InjuryJun 3, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
A TREATMENT WAS COMPLETED ON A PATIENT AND WHEN STAFF STARTED TO REMOVE THE BOTTLES, CONTAMINATION WAS DISCOVERED. IT LOOKS LIKE MOLD. STAFF INSPECTED THE REMAINING BOTTLES IN THEIR AREA AND FOUND ANOTHER BOTTLE THAT HAD WHAT LOOKED LIKE MOLD FORMING AS WELL. PATIENT OUTCOME UNKNOWN. CULTURE OF THE SUBSTANCE IN THE JUG CAME BACK AS GRAM POSITIVE RODS
Patient problems: Insufficient Information
MAUDE report 22134119 ↗MalfunctionJun 3, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
CUSTOMER REPORTED FOREIGN SUBSTANCE FOUND IN THE LIQUID BICARB. NO PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22134118 ↗MalfunctionJun 3, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
CUSTOMER REPORTED FOREIGN SUBSTANCE FOUND IN THE LIQUID BICARB. NO PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22134111 ↗MalfunctionJun 3, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
CUSTOMER REPORTED FOREIGN SUBSTANCE FOUND IN THE LIQUID BICARB. NO PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22134110 ↗MalfunctionJun 3, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
CUSTOMER REPORTED FOREIGN SUBSTANCE FOUND IN THE LIQUID BICARB. NO PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22134109 ↗MalfunctionJun 3, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
CUSTOMER REPORTED FOREIGN SUBSTANCE FOUND IN THE LIQUID BICARB. NO PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22134108 ↗MalfunctionJun 3, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
CUSTOMER REPORTED FOREIGN SUBSTANCE FOUND IN THE LIQUID BICARB. NO PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22134105 ↗MalfunctionJun 2, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
CUSTOMER REPORTED FOREIGN SUBSTANCE FOUND IN THE LIQUID BICARB. NO PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22122944 ↗MalfunctionJun 2, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
CUSTOMER REPORTED FOREIGN SUBSTANCE FOUND IN THE LIQUID BICARB. NO PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22122936 ↗MalfunctionJun 2, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
CUSTOMER REPORTED FOREIGN SUBSTANCE FOUND IN THE LIQUID BICARB. NO PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22122935 ↗MalfunctionJun 2, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
CUSTOMER REPORTED FOREIGN SUBSTANCE FOUND IN THE LIQUID BICARB. NO PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22122933 ↗MalfunctionJun 2, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
CUSTOMER REPORTED FOREIGN SUBSTANCE FOUND IN THE LIQUID BICARB. NO PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22122932 ↗MalfunctionJun 2, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
CUSTOMER REPORTED FOREIGN SUBSTANCE FOUND IN THE LIQUID BICARB. NO PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22122930 ↗MalfunctionJun 2, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
CUSTOMER REPORTED FOREIGN SUBSTANCE FOUND IN THE LIQUID BICARB. NO PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22122929 ↗MalfunctionJun 2, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
CUSTOMER REPORTED FOREIGN SUBSTANCE FOUND IN THE LIQUID BICARB. NO PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22122927 ↗MalfunctionJun 2, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
CUSTOMER REPORTED FOREIGN SUBSTANCE FOUND IN THE LIQUID BICARB. NO PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22122924 ↗MalfunctionJun 2, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
CUSTOMER REPORTED FOREIGN SUBSTANCE FOUND IN THE LIQUID BICARB. NO PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22122923 ↗MalfunctionJun 2, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
CUSTOMER REPORTED FOREIGN SUBSTANCE FOUND IN THE LIQUID BICARB. NO PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22122922 ↗MalfunctionJun 2, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
CUSTOMER REPORTED FOREIGN SUBSTANCE FOUND IN THE LIQUID BICARB. NO PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22122921 ↗MalfunctionJun 2, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
CUSTOMER REPORTED FOREIGN SUBSTANCE FOUND IN THE LIQUID BICARB. NO PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22122920 ↗MalfunctionJun 2, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
CUSTOMER REPORTED FOREIGN SUBSTANCE FOUND IN THE LIQUID BICARB. NO PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22122918 ↗MalfunctionJun 2, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
CUSTOMER REPORTED FOREIGN SUBSTANCE FOUND IN THE LIQUID BICARB. NO PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22122914 ↗MalfunctionJun 2, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
CUSTOMER REPORTED FOREIGN SUBSTANCE FOUND IN THE LIQUID BICARB. NO PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22122913 ↗MalfunctionJun 2, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
CUSTOMER REPORTED FOREIGN SUBSTANCE FOUND IN THE LIQUID BICARB. NO PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22122912 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K012547. One submission often covers many models, so check the product and lot details in each record.
- Z-3133-2026 · Aug 5, 2026 · Open, ClassifiedMedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201
Other Dialysate Concentrate For Hemodialysis (Liquid Or Powder) devices
- NaturaLyte 08-3251-9Fresenius Medical Care Renal Therapies Group, LLC · DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)2 recalls78 reports
- NaturaLyte 08-2251-0Fresenius Medical Care Renal Therapies Group, LLC · DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)3 recalls1 death20 reports
- NaturaLyte 08-2301-3Fresenius Medical Care Renal Therapies Group, LLC · DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)2 recalls35 reports
- Dry Acid Dissolution Unit 160147Fresenius Usa, Inc. · DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)129 reports
- GranuFlo 0FD2251-3BFresenius Medical Care Renal Therapies Group, LLC · DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)2 recalls1 death20 reports
- GranuFlo 0FD3251-3BFresenius Medical Care Renal Therapies Group, LLC · DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)2 recalls1 death1 report
- Acidified Concentrate Distribution and Storage (ACDS) System MD704262Isopure, Corp. · Dialysate Concentrate For Hemodialysis (Liquid Or Powder)2 recalls0 reports
- Bicarby RFP-400-GFresenius Medical Care Renal Therapies Group, LLC · Dialysate Concentrate For Hemodialysis (Liquid Or Powder)2 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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