MedicaLyte Liquid Bicarbonate Concentrate. Model Numbers: BC+201 (45X), BC+100 36.83X. Plastic bottle packaged in cor
Summary
The FDA issued a Class I for MedicaLyte Liquid Bicarbonate Concentrate. Model Numbers: BC+201 (45X), BC+100 3 by Nipro Renal Soultions USA, Corporation. Reason: Potential for the presence of visible foreign matter..
Details
Source
Device Recall
External ID
Z-1730-2025
Action Date
2025-05-21
Status
Ongoing
Category
device
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).
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.
Quantity Affected: 816,840 units (BC+201), 39,228 units (BC+100)
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-04-11
Company
Lewisberry, PA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 152 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Nipro Renal Soultions USA, Corporation has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Nipro Renal Soultions USA, Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Nipro Renal Soultions USA, Corporation have FDA actions?
Nipro Renal Soultions USA, Corporation has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1730-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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