BEUDAMED
    FDA Enforcement Class II Ongoing

    Procedure packs: (1) Presource Portacath Pack, Cat. SANV1PIFSB, Medstar Franklin Square Med CE, Sterile; and (2) Presource Bone Marrow Harvest Pack, Cat. SAN12BHGT1, Medstar Georgtown University H, Sterile.

    Recall: Z-0088-2024 · Reported October 18, 2023

    Enforcement

    Recall Number
    Z-0088-2024
    Event ID
    92875
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Cardinal Health 200, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 18, 2023
    Initiation Date
    August 16, 2023
    Classification Date
    October 10, 2023
    Address
    3651 Birchwood Dr, N/A, Waukegan, IL, 60085-8337, United States

    Description

    Procedure packs: (1) Presource Portacath Pack, Cat. SANV1PIFSB, Medstar Franklin Square Med CE, Sterile; and (2) Presource Bone Marrow Harvest Pack, Cat. SAN12BHGT1, Medstar Georgtown University H, Sterile.

    Reason

    Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).

    Code Info

    (1) Cat. SANV1PIFSB - Lot #67711, Exp. 3/1/2026, UDI-DI 10195594532048; and (2) Cat. SAN12BHGT1 - Lot #13526, Exp. 3/1/2024, UDI-DI 10197106202715.

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, DC, FL, HI, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, and WV. There was government distribution and no military distribution. The country of Canada.

    Quantity

    13,351 total packs