FDA-Device2026-09-16Class IIPROCESSING DEFECT
Nipro MedicaLyte Liquid Bicarbonate Concentrate recalled for high endotoxin levels in hemodialysis concentrate
What this means
Nipro Renal Solutions USA recalled certain lots of MedicaLyte Liquid Bicarbonate Concentrate (models BC-100 and BC+201) used in hemodialysis because they contain elevated endotoxin levels. High endotoxin in dialysis concentrates can cause serious reactions during treatment.
- Check your dialysis center's supply against the affected lot numbers: BC-100 lots N4L022 and N4L037, or BC+201 lot N4L010
- Contact your dialysis center or Nipro if you have questions about whether your treatment used affected product
- Do not use recalled lots if your facility has them in stock
The agency's original wording
Hazard
Hemodialysis concentrates contain high endotoxin levels
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
3,286 cases
Manufactured in
509 Fishing Creek Rd, Lewisberry, PA, United States
Products
MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3133-2026More Nipro recalls
- FDA-Device2026-09-16Nipro Citric Complete Dry Citric Acid Concentrate recalled for high endotoxin levels
- FDA-Device2026-09-16Nipro MedicaLyte Bicarbonate Powder recalled for high endotoxin levels in hemodialysis concentrate
- FDA-Device2026-09-16Nipro Renal Solutions Citric Complete hemodialysis concentrate recalled for high endotoxin levels
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