BEUDAMED
    FDA Enforcement Class II Terminated

    Custom Procedure Kit, Cardiac Cath Pack, Product Code: K12T-10996 Rev. B, Sterile EO, Rx Only, (01)00884450515105 For Angiography/angioplasty. The contents of the kit are surgical drapes, gowns, towels, medicine cups, needles, various bowls, pen and label set (PAL), scalpel, several syringes, chloraprep, table cover, and gauze to be used in a Cardiac Cath procedure.

    Recall: Z-0751-2021 · Reported January 6, 2021

    Enforcement

    Recall Number
    Z-0751-2021
    Event ID
    86831
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Merit Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 6, 2021
    Initiation Date
    November 10, 2020
    Classification Date
    December 29, 2020
    Termination Date
    October 5, 2022
    Address
    1600 W Merit Pkwy, N/A, South Jordan, UT, 84095-2416, United States

    Description

    Custom Procedure Kit, Cardiac Cath Pack, Product Code: K12T-10996 Rev. B, Sterile EO, Rx Only, (01)00884450515105 For Angiography/angioplasty. The contents of the kit are surgical drapes, gowns, towels, medicine cups, needles, various bowls, pen and label set (PAL), scalpel, several syringes, chloraprep, table cover, and gauze to be used in a Cardiac Cath procedure.

    Reason

    Angiography/Angioplasty custom kits contain header bags which may not be fully sealed, resulting in a compromised sterile barrier. This could result in exposure to non-sterile devices which may lead to an infection requiring medical treatment.

    Code Info

    (01)00884450515105 Lot # T1907711,

    Distribution

    US distribution to: KY, RI, and MD

    Quantity

    80 kits