Medical device recalls High risk

MedicaLyte Liquid Bicarbonate Concentrate recalled over foreign material

Recall date
April 11, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Nipro Renal Soultions USA, Corporation recalls MedicaLyte Liquid Bicarbonate Concentrate. Model Numbers: BC+201 (45X), BC+100 36.83X. Plastic bottle packaged in corru…
Recall number
Z-1730-2025
FDA classification
Class I
Brand / firm
Nipro Renal Soultions USA, Corporation
Sold / distributed
US Nationwide distribution in the states of AZ, CA, CO, DE, FL, GA, IL, KS, LA, MA, MI, MN, MO, NC, NJ, NV, NY, OH, OK, OR, PA, SC, TX, UT, VA, WA, PR. International distribution to Guatemala and Panama.

Why it was recalled

Potential for the presence of visible foreign matter.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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).

Get recall alerts

Free email alert whenever Nipro Renal Soultions USA, Corporation has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: Nipro Renal Soultions USA, Corporation