FDA Medical Device Recalls (openFDA)
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 shipper case).
- Recall number
- Z-1730-2025
- Recalling firm
- Nipro Renal Soultions USA, Corporation
- 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).
- Status
- Open, Classified
- Initiated
- 2025-04-11
- Posted
- 2025-05-14
- Terminated
- not on file
- Reason
- Potential for the presence of visible foreign matter.
- Root cause
- Process control
- Action
- 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.
- Quantity
- 816,840 units (BC+201), 39,228 units (BC+100)
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- K012547
- PMA numbers
- not on file
- Product code
- KPO
- Firm FEI
- 1000142899
- Firm city
- Lewisberry
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28