BEUDAMED
    FDA Enforcement Class II Terminated

    KIT, PRE OP DRAH - Product Usage: Preoperative kit used to decolonize intranasal S. aureus.

    Recall: Z-3016-2020 · Reported October 7, 2020

    Enforcement

    Recall Number
    Z-3016-2020
    Event ID
    86178
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cardinal Health 200, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 7, 2020
    Initiation Date
    July 30, 2020
    Classification Date
    September 25, 2020
    Termination Date
    April 28, 2021
    Address
    785 Fort Mill Hwy, N/A, Fort Mill, SC, 29707-7555, United States

    Description

    KIT, PRE OP DRAH - Product Usage: Preoperative kit used to decolonize intranasal S. aureus.

    Reason

    Only providing one nasal swab in our pre-operative kit instead of the 4 required for proper treatment.

    Code Info

    Model: ORPDH5994A Lot numbers: 558357, 561502,566549, 571467, 574058. Expiration dates: Varies by kit components.

    Distribution

    US Nationwide distribution including the state of North Carolina.

    Quantity

    9,150 kits