Reported May 21, 2025 · Ongoing

MedicaLyte Liquid Bicarbonate Concentrate. Model Numbers: BC+201 (45X), BC+100 36.83X. Plastic bottle packaged in…

Nipro Renal Soultions USA, Corporation

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Nipro Renal Soultions USA, Corporation · 509 Fishing Creek Rd · Lewisberry, PA · 17339-9517

Is this the product you have?

  • MedicaLyte Liquid Bicarbonate Concentrate
  • Model NumbersBC+201 (45X), BC+100 36.83X. Plastic bottle packaged in corrugated shipper cases (4 bottles per shipper case)
Lot codes and dates

4 of 4 products

Products covered by this recall
#BarcodesProduct as published
11081741102282100817411022824Model Number: BC+201 (45X). Case UDI-DI: 10817411022821, Bottle UDI-DI: 00817411022824. All
2lot numbers. b.
31081741102281400817411022817Model Number: BC+100 36.83X. Case UDI-DI: 10817411022814, Bottle UDI-DI 00817411022817.
4Lot Numbers: N3C014, N3C018, N3F018, N4C010, N4C012, N4E004, N4L021, N4L022, N4L037, N5A044.
Amount recalled
816,840 units (BC+201), 39,228 units (BC+100)

Where it was sold

Why it was recalled

Stop using this product now

Potential for the presence of visible foreign matter.

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 3:28 PM UTC

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