BEUDAMED
    FDA Enforcement Class II Terminated

    Protexis Neoprene Surgical Glove, Size 8.5 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

    Recall: Z-0637-2019 · Reported December 26, 2018

    Enforcement

    Recall Number
    Z-0637-2019
    Event ID
    81579
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cardinal Health 200, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 26, 2018
    Initiation Date
    October 31, 2018
    Classification Date
    December 18, 2018
    Termination Date
    August 12, 2025
    Address
    3651 Birchwood Dr, Waukegan, IL, 60085-8337, United States

    Description

    Protexis Neoprene Surgical Glove, Size 8.5 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

    Reason

    Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene surgical gloves are incorrect. Additionally, breakthrough times for Mitomycin were added to the same label in error.

    Code Info

    Product code: 2D73DP85, Lot Numbers: TS18060015, TS18060329, TS18070121, TS18070314, TS18080034, TS18080352, and TS18090219.

    Distribution

    Worldwide Distribution: US (Nationwide distribution) to states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and to countries of: Austria, Belgium, Canada, Chile, Costa Rica, France, Germany, Italy, Luxembourg, Martinique, Monaco, Netherlands, Poland, Reunion, Spain, Sweden, Switzerland, Taiwan, and United Kingdom.

    Quantity

    1,475,095 pairs total