Home / Recalls / Nipro Renal Soultions USA, Corporation / Z-1730-2025

Z-1730-2025 Class I Ongoing

Recalled by Nipro Renal Soultions USA, Corporation — Lewisberry, PA

Recall Details

Product Type: Devices
Report Date: May 21, 2025
Initiation Date: April 11, 2025
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 816,840 units (BC+201), 39,228 units (BC+100)

Product Description

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 Pattern

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.

Code Information

a. Model Number: BC+201 (45X). Case UDI-DI: 10817411022821, Bottle UDI-DI: 00817411022824. All lot numbers. b. Model Number: BC+100 36.83X. Case UDI-DI: 10817411022814, Bottle UDI-DI 00817411022817. Lot Numbers: N3C014, N3C018, N3F018, N4C010, N4C012, N4E004, N4L021, N4L022, N4L037, N5A044.