FDA recall Z-1730-2025

Nipro Renal Soultions USA, Corporation · Class I · device

Product

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).

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.

Key facts

Status
Ongoing
Initiation date
2025-04-11
Report date
2025-05-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lewisberry, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1730-2025