BEUDAMED
    FDA Recall Open, Classified

    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482

    Recall: Z-0575-2022 · Initiated January 7, 2022

    Recall

    Recall Number
    Z-0575-2022
    Event Number
    89327
    Firm
    Baxter Healthcare Corporation
    FEI Number
    1417572
    Product Code
    KDJ
    Status
    Open, Classified
    Root Cause
    Other
    Initiated
    January 7, 2022
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    Description

    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482

    Reason

    Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.

    Action

    Baxter disseminated a Urgent Medical Device Correction letter on 7 January 2022 to peritoneal dialysis centers and will follow with notice to the patients on 12 January 2022. The notices warned that the use of cleaning products and solvents may cause damage (for example, leaking or cracking), if they come into direct contact with the transfer set. Baxter will be updating the Instructions for Use (IFU) to include a warning against the use of these cleaning products and solvents. For general questions regarding this communication, contact Baxter Corporate Product Surveillance at 800-437-5176.

    Distribution

    Worldwide

    Quantity

    449,676 units