Official recall notice
FDA DeviceClass IINotable
FDA Recall: MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201
- Recall date
- 2026-09-16
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Hemodialysis concentrates contain high endotoxin levels
Product description
Hemodialysis concentrates contain high endotoxin levels
Affected products
BC-100 - Lot:N4L022 (exp.11/13/2026), N4L037(exp.11/18/2026) BC+201- Lot: N4L010(exp.11/06/2026)