MedicaLyte Bicarbonate (Nipro) – Foreign Matter Risk (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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).
Brand
Nipro Renal Soultions USA, Corporation
Lot Codes / Batch Numbers
a. Model Number: BC+201 (45X). Case UDI-DI: 10817411022821, Bottle UDI-DI 00817411022817. Lot Numbers: N3C014, N3C018, N3F018, N4C010, N4C012, N4E004, N4L021, N4L022, N4L037, N5A044.
Products Sold
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.
Nipro Renal Soultions USA, Corporation is recalling MedicaLyte Liquid Bicarbonate Concentrate. Model Numbers: BC+201 (45X), BC+100 36.83X. Plastic bo due to Potential for the presence of visible foreign matter.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for the presence of visible foreign matter.
Recommended Action
Per FDA guidance
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 Nipro4621@sedgwick.com 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: jessicao@nipromed.com. 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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026