FDAApril 11, 2025device
MedicaLyte Liquid Bicarbonate Concentrate. Model Numbers: BC+201 (45X), BC+100 36.83X. Plastic bottle packaged in corrugated shipper cases (4 bottles per shipper case).
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Potential for the presence of visible foreign matter.
What to do
FDA enforcement status: Ongoing
Brands named
nipro renal soultionsnipronipro renal
UPCs
10817411022821008174110228241081741102281400817411022817
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAConductivity Standard Solution Catalog/Model Numbers: 10001, 10011, 10021, 10032, 10040, 10040c, and 10041 Conductivity Standard Solutions are a secondary standard solution used for the calibration of conductivity cells together with conductivity meters2025-12-12
- FDAHemodialysis System, Surdial DX REF: MC+SDX01 Rx Only2025-10-27
- FDACitric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-252024-11-22
- FDALiberty Cycler Cassettes (a disposable cassette that is intended to be used to perform peritoneal dialysis (APD) in conjunction with the Liberty cycler as follows: (1) LIBERTY Line Cycler Set with Stay-safe connectors (Dual Patient Connector) Part Number: 050-87212 (2) LIBERTY Line Cycler Set wit...2019-05-29
- FDA2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 - Product Usage: The 2008T hemodialysis machine is indicated for acute and chronic dialysis therapy in a healthcare facility.2019-04-03
- FDAOptiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E2018-11-05
- FDAFresenius Granuflo Dry Acid Concentrate- 2K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B for hemodialysis2018-10-09
- FDAFresenius Granuflo Dry Acid Concentrate- 3K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD3251-3B for hemodialysis2018-10-09
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