BEUDAMED
    FDA Recall Open, Classified

    Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P; Accessory to disposable administration set for peritoneal dialysis

    Recall: Z-1213-2023 · Initiated February 1, 2023

    Recall

    Recall Number
    Z-1213-2023
    Event Number
    91612
    Firm
    Baxter Healthcare Corporation
    FEI Number
    1417572
    Product Code
    KDJ
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    February 1, 2023
    Posted
    March 3, 2023
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    Description

    Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P; Accessory to disposable administration set for peritoneal dialysis

    Reason

    MiniCap Disconnect Cap with Povidone-Iodine are packaged in foil pouches, which may have been incorrectly sealed, i.e., the pouches may have open or weak seals. This could lead to exposure to air, resulting in insufficient iodine/dry sponge inside the MiniCap, which could lead to the potential for inadequate disinfectant.

    Action

    Baxter Healthcare initiated the recall by issuing an Urgent Medical Device Recall notice to its consignees by letter on 02/01/2023. The notice requested the following from customers: 1. Check your stock and set aside all product with the affected lot numbers. 2. Contact Baxter HomeCare Services to arrange for return of impacted product and for ordering replacement product. 3. If all of your product is impacted by this recall and you are unable to get unaffected lot numbers, resulting in a significant delay in therapy, please follow the below steps: a. Contact your clinic for clinical guidance and check each pouch and do not use the MiniCap contained inside of any pouches that appear to have damaged seals. For general questions regarding this communication, contact Baxter Corporate Product Surveillance at 800-437-5176, between the hours of 8:00 am and 5:00 pm Central Time, Monday through Friday." Recall was expanded and Baxter Healthcare sent an updated notification to customers and patients on 05/09/2023. The letter instructed consignees and patients to immediately cease use of the affected product, arrange for the return of affected product and assess each patient's individual next steps based on clinical evaluation. Customers were also instructed to complete the customer response form via the portal (for products directly received from Baxter) or through the distributor. If the products were further distributed, please notify customers.

    Distribution

    US Nationwide distribution and Canada.

    Quantity

    33,866,400 units