BEUDAMED
    FDA Recall Terminated

    Protek Solo Venous Dilator Set: dilator, vessel, for percutaneous catheterization. Catalog #: 5840-2417 - LS Tandem Life Kit - V24/A17 Catalog #: 5840-2415 - LS Tandem Life Kit - V24/A15 Catalog #: 5740-2417 - TandemLife Kit - V24/A17 Catalog #: 5100-1422 - ProtekSolo Venous Dilator Set (14-22 Fr)

    Recall: Z-1486-2021 · Initiated March 19, 2021

    Recall

    Recall Number
    Z-1486-2021
    Event Number
    87632
    Firm
    Cardiac Assist, Inc
    FEI Number
    3002228812
    Product Code
    DRE
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    March 19, 2021
    Terminated
    November 22, 2021
    Address
    240 Alpha Dr, Pittsburgh, PA, 15238-2906

    Description

    Protek Solo Venous Dilator Set: dilator, vessel, for percutaneous catheterization. Catalog #: 5840-2417 - LS Tandem Life Kit - V24/A17 Catalog #: 5840-2415 - LS Tandem Life Kit - V24/A15 Catalog #: 5740-2417 - TandemLife Kit - V24/A17 Catalog #: 5100-1422 - ProtekSolo Venous Dilator Set (14-22 Fr)

    Reason

    On 02/26/2021, it was found that there were incorrectly packaged Dilator sets in Finished Goods. On 03/1/2021, it was confirmed that 14 kits containing the impacted products had been distributed to the field.

    Action

    On 3/11/2021 LivaNova issued an Urgent Medical Device Correction notice via letter notifying customers the firm identified an error with the assembly of a limited number of ProtekSolo Venous Dilator Sets. The ProtekSolo Venous Dilator Set 14-22 Fr should contain 3 dilators: 14Fr, 18Fr and 22Fr. A limited number of boxes labeled as ProtekSolo Venous Dilator Set 14-22 Fr incorrectly contain 4 dilators: 14Fr, 18Fr, 22Fr and 26Fr.

    Distribution

    US Nationwide distribution in the states of AL, AZ, IL, TN.

    Quantity

    13 kits