BEUDAMED
    FDA Recall 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 · Initiated October 31, 2018

    Recall

    Recall Number
    Z-0637-2019
    Event Number
    81579
    Firm
    Cardinal Health 200, LLC
    FEI Number
    3001236905
    Product Code
    KGO
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    October 31, 2018
    Terminated
    August 12, 2025
    Address
    3651 Birchwood Dr, Waukegan, IL, 60085-8337

    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.

    Action

    Cardinal Health notified customers on about 10/31/2018 via "URGENT: PRODUCT CORRECTION NOTICE." Customers were instructed to examine inventory for affected products, affix the provided warning label on the principal display panel on the affected dispenser packs, notify internal parties and/or customers if the product was further distributed of the recall, and complete and return the provided Acknowledgement Form. If the wallets containing the gloves are removed from the dispenser packs, customers were also instructed to provide a warning label to accompany the affected product inform users of the correct breakthrough times. If customers need additional labels, they were instructed to contact 800-292-9332 or [email protected] for assistance. For further questions regarding the Product Correction Notice, please reference the following Customer Service telephone numbers: Hospital (800-964-5227), Federal Government (800-444-1166), Distributor (800-635-6021), All other customers (888-444-5440).

    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