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MedicaLyte Liquid Bicarbonate Concentrate. Model Numbers:… recallZ-1730-2025 · Nipro Renal Soultions USA, Corporation · initiated Apr 11, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Nipro Renal Soultions USA, Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Potential for the presence of visible foreign matter.

FDA root cause category: Process control

What the company is doing

Nipro Renal notified consignees on about 04/11/2025 via "URGENT: MEDICAL DEVICE RECALL" letter dated 4/10/2025. Consignees were instructed to identify and isolate any inventory from the affected BC+201 lots, cease use of those affected lots, complete and return the Business Reply Card even if you do not have the recalled product to [email protected] or via fax to 877-496-5036 and arrange the return of any affected lots on hand via phone 1-877-546-0126. Additionally, consignees were instructed to notify any accounts if lots were further distributed. If you have any questions, call 305- 432-6699 or email: [email protected]. Nipro expanded the recall and notified specific international consignees on about 05/30/2025 concerning affected BC+100 lots. Customers were provided the same instructions to return all affected units and notify customers if further distributed On 06/02/2025, Nipro Renal expanded the recall again to include all BC+201 lot numbers and notified consignees via letter. The letter notified consignees that all lots were affected and instructed them to cease distribution, quarantine any on hand, complete and return the response form, and arrange for return of any lots on hand. Additionally, customers were instructed to forward the notification to customers if further distributed.

Recall details

Recall number
Z-1730-2025
Status
Open, Classified
Initiated by the company
Apr 11, 2025
Posted by the FDA
May 14, 2025
Recalling firm
Nipro Renal Soultions USA, Corporation
Quantity
816,840 units (BC+201), 39,228 units (BC+100)
Product code
KPO
FDA submissions
K012547
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.

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).

Code information (models, lots, serial numbers)

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.

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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