Nipro Renal Soultions USA, Corporation: MedicaLyte Liquid Bicarbonate Concentrate. Model Numbers: BC+201 (45X), BC+100 36.83X. Plastic bottle packaged in corrugated shipper cases (4 bottles per shippe

Hazard

Potential for the presence of visible foreign matter.

Details from the source

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. Quantity: 816,840 units (BC+201), 39,228 units (BC+100) Lot/code info: 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.

UPC codes

10817411022821, 00817411022824, 10817411022814, 00817411022817

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.