BEUDAMED
    FDA Enforcement Class II Terminated

    ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Patient Preoperative Skin Preparation, Non-sterile Solution, 10.5 ml Applicator, Hi-Lite Orange, NDC 054365-400-12, Cat. No. 260715NS, a component of Vein Tray K12T-10167 - Product Usage: For the preparation of the patient's skin prior to surgery. Helps to reduce bacteria that potentially can cause skin infection.

    Recall: Z-1702-2020 · Reported April 22, 2020

    Enforcement

    Recall Number
    Z-1702-2020
    Event ID
    85171
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Merit Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    April 22, 2020
    Initiation Date
    July 9, 2018
    Classification Date
    April 13, 2020
    Termination Date
    April 14, 2020
    Address
    1600 W Merit Pkwy, South Jordan, UT, 84095-2416, United States

    Description

    ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Patient Preoperative Skin Preparation, Non-sterile Solution, 10.5 ml Applicator, Hi-Lite Orange, NDC 054365-400-12, Cat. No. 260715NS, a component of Vein Tray K12T-10167 - Product Usage: For the preparation of the patient's skin prior to surgery. Helps to reduce bacteria that potentially can cause skin infection.

    Reason

    A nonsterile bulk product designated for further processing in a tray was inadvertently shipped to a customer.

    Code Info

    Merit lot number J559821

    Distribution

    US Nationwide distribution in the state of IL. There was no other distribution.

    Quantity

    6 units