FDA-Device2025-05-21Class I
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
Hazard
Potential for the presence of visible foreign matter.
Sold states
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.
Affected count
816,840 units (BC+201), 39,228 units (BC+100)
Manufactured in
509 Fishing Creek Rd, Lewisberry, PA, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1730-2025Don't want to check this manually?
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