BEUDAMED
    FDA Enforcement Class II Terminated

    LASER CDS

    Recall: Z-2980-2018 · Reported September 12, 2018

    Enforcement

    Recall Number
    Z-2980-2018
    Event ID
    78411
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medline Industries, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    September 12, 2018
    Initiation Date
    April 12, 2017
    Classification Date
    September 6, 2018
    Termination Date
    August 5, 2019
    Address
    1170 S Northpoint Blvd, N/A, Waukegan, IL, 60085-6757, United States

    Description

    LASER CDS

    Reason

    Multiple surgical packs were assembled with a non-sterile CHG applicators labeled as "ChloraPrep" (kit component numbers: 29183, 52115, 82279, and 82281). The non-sterile components 29183, 52115, 82279, and 82281 should have been placed inside the sterile portion of the pack, where it would subsequently be exposed to the ethylene oxide sterilization process. However, the components were not placed in the sterile portion of the pack during assembly and were never exposed to the sterilization process. Components 29183, 52115, 82279, and 82281 were inadvertently released non-sterile. The remainder of the pack components were properly sterilized and only components 29183, 52115, 82279, and 82281 were affected. Components 29183, 52115, 82279, and 82281 are manufactured by Becton, Dickinson (BD) and are labeled "ChloraPrep". ChloraPrep" applicators contain 2% w/v chlorhexidine gluconate (CHG) in 70% v/v isopropyl alcohol (IPA). The applicators are used to facilitate skin preparation for various preoperative and pre-injection procedures.

    Code Info

    Model: CDS980970D; Lots: 16FD2090, 16GD2340, 16ID0038, 16KD1940, 17BD1440, 17CD2208

    Distribution

    CA, NM

    Quantity

    144 kits