BEUDAMED
    FDA Recall Terminated

    LIPOSORBER System, Model: LA-15, consisting of: Apheresis machine, product# 101445 model: MA-03, and disposables (product#, model) [#101447, KP-05 Sulflux Plasma Separator], [#101473, HDE KP-05 Sulflux Plasma Separator], [#101785, LA-15 (AU) LDL Adsorption Column (Luer Lock Type)], [#101786, NK-M3R(UL) Tubing (Luer Lock Type)], [#101788, HDE LA-15(AU) LDL Adsorption Column (Luer Lock Type)], [#101789, HDE NK-M3R(UL) Tubing (Luer Lock Type)]. Associated labeling: 1) Instructions for Use (6): IFU LIPOSORBER LA-15 LDL Adsorption Columns FH, IFU SULFLUX KP-05 PLASMA SE-PARATOR FH, IFU TUBING SYSTEM FOR PLASMAPHERESIS NK-M3R(UL) FH, IFU LIPOSORBER LA-15 LDL Adsorption Columns FSGS, IFU SULFLUX KP-05 PLASMA SE-PARATOR FSGS, IFU TUBING SYSTEM FOR PLASMAPHERESIS NK-M3R(UL) FSGS, 2) Operators Manuals for the following (2): LIPOSORBER LA-15 SYSTEM OPERATOR's MANUAL FH, LIPOSORBER LA-15 SYSTEM OPERATOR's MANUAL FSGS 3) Patients Guide (1): A PATIENT GUIDE TO THE LIPOSORBER LA-15 SYSTEM FSGS

    Recall: Z-0900-2022 · Initiated February 17, 2022

    Recall

    Recall Number
    Z-0900-2022
    Event Number
    89735
    Firm
    Kaneka America Corp
    FEI Number
    2435151
    Product Code
    MMY
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    February 17, 2022
    Terminated
    May 6, 2024
    Address
    546 5th Ave, Fl 21, New York, NY, 10036-5000

    Description

    LIPOSORBER System, Model: LA-15, consisting of: Apheresis machine, product# 101445 model: MA-03, and disposables (product#, model) [#101447, KP-05 Sulflux Plasma Separator], [#101473, HDE KP-05 Sulflux Plasma Separator], [#101785, LA-15 (AU) LDL Adsorption Column (Luer Lock Type)], [#101786, NK-M3R(UL) Tubing (Luer Lock Type)], [#101788, HDE LA-15(AU) LDL Adsorption Column (Luer Lock Type)], [#101789, HDE NK-M3R(UL) Tubing (Luer Lock Type)]. Associated labeling: 1) Instructions for Use (6): IFU LIPOSORBER LA-15 LDL Adsorption Columns FH, IFU SULFLUX KP-05 PLASMA SE-PARATOR FH, IFU TUBING SYSTEM FOR PLASMAPHERESIS NK-M3R(UL) FH, IFU LIPOSORBER LA-15 LDL Adsorption Columns FSGS, IFU SULFLUX KP-05 PLASMA SE-PARATOR FSGS, IFU TUBING SYSTEM FOR PLASMAPHERESIS NK-M3R(UL) FSGS, 2) Operators Manuals for the following (2): LIPOSORBER LA-15 SYSTEM OPERATOR's MANUAL FH, LIPOSORBER LA-15 SYSTEM OPERATOR's MANUAL FSGS 3) Patients Guide (1): A PATIENT GUIDE TO THE LIPOSORBER LA-15 SYSTEM FSGS

    Reason

    Labeling change to due to the risk of severe anaphylactoid reactions including shock in patients treated with the Liposorber LA-15 LDL Adsorption Column under concomitant ACE inhibitor medication treatment.

    Action

    On 02/17/2022 a recall notification letter with revised labeling was emailed regarding contraindication in patients who are being treated with angiotensin-converting enzyme (ACE) inhibitors. Customers are to locate, destroy and replace all operator's manuals, patient guides, and IFUs with those attached to the recall notice, ensuring they are distributed to all end users. All device model, lot, and UDI numbers for systems and disposables are affected. Submit the Acknowledgement and Receipt Form to Kaneka Medical America, LLC via email. If you have any question or concerns about this recall please contact Kaneka Medical America LLC Monday through Friday, 8:00 AM to 4:30 PM, Eastern Time, at: Phone: (212) 705-4355, Email: [email protected]

    Distribution

    US only: CA, NH, CT, MA, FL, DE, NY, NJ, PA, OH, MD, VA, NC, SC, GA, MS, TN, TX, IN, AZ, MI, WI, MN, IL, MO, NE, CO, WA, OR, UT, KS, OK, AL, ME

    Quantity

    138 Systems, 54703 disposables