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Recall Observatory FDA recall evidence

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).

Z-1730-2025

April 11, 2025

Class I

Product summary

Firm
Nipro Renal Soultions USA, Corporation
Event
Event 96646
Status
Ongoing
Classification
Class I
Quantity
816,840 units (BC+201), 39,228 units (BC+100)
Official record key
device-enforcement:Z-1730-2025

Official wording

Reason: Potential for the presence of visible foreign matter.

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.

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.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    foreign matter