FDA · Medical devices ·
MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201 recall
Nipro Renal Soultions USA, Corporation recalled MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201 on September 16, 2026 because of hemodialysis concentrates contain high endotoxin levels. It was sold nationwide.
Why it was recalled
Hemodialysis concentrates contain high endotoxin levels
What's recalled
MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201
Quantity: 3,286 cases
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- Nipro Renal Soultions USA, Corporation, Lewisberry, PA
- Date
- Severity
- Class II
the product could cause temporary or reversible health problems. - Where sold
- Nationwide
Worldwide - US Nationwide distribution in the states of FL, GA, IL, MD, MI, NC, NJ, NV, OH, PA, and the countries of Guatemala and Panama. - Status
- Ongoing
- Recall number
- Z-3133-2026
- Source
- U.S. Food and Drug Administration
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