Class I

Medical Device Recall: 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).

Nipro Renal Soultions USA, Corporation · April 11, 2025

Reason for Recall

Potential for the presence of visible foreign matter.

Distribution

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.

States Affected

NATIONWIDE

Quantity Affected

816,840 units (BC+201), 39,228 units (BC+100)

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1730-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Nipro Renal Soultions USA, Corporation Medical Device Recall: 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). | SafeCheck