BEUDAMED
    FDA Recall Open, Classified

    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: Z-1730-2025 · Initiated April 11, 2025

    Recall

    Recall Number
    Z-1730-2025
    Event Number
    96646
    Firm
    Nipro Renal Soultions USA, Corporation
    FEI Number
    1000142899
    Product Code
    KPO
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    April 11, 2025
    Posted
    May 14, 2025
    Address
    509 Fishing Creek Rd, Lewisberry, PA, 17339-9517

    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).

    Reason

    Potential for the presence of visible foreign matter.

    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 [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.

    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.

    Quantity

    816,840 units (BC+201), 39,228 units (BC+100)