BEUDAMED
    FDA Enforcement Class II Terminated

    Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micron Filter Set Non-Vented, Microbore, PAV, CLAVE Y-Site, 122 Inch. 1 unit per pouch; 50 pouches per case

    Recall: Z-0133-2020 · Reported October 23, 2019

    Enforcement

    Recall Number
    Z-0133-2020
    Event ID
    83549
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ICU Medical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 23, 2019
    Initiation Date
    July 29, 2019
    Classification Date
    October 14, 2019
    Termination Date
    January 12, 2024
    Address
    600 N Field Dr, N/A, Lake Forest, IL, 60045-4835, United States

    Description

    Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micron Filter Set Non-Vented, Microbore, PAV, CLAVE Y-Site, 122 Inch. 1 unit per pouch; 50 pouches per case

    Reason

    Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

    Code Info

    Product Code: 163830455, Lot number (UDI Number): 855665H (20887787007439, 10887787007432), 865495H (20887787007439, 10887787007432), 896195H (20887787007439, 10887787007432), 3849197 (20887787007439, 10887787007432), 4064964 (20887787007439, 10887787007432)

    Distribution

    Nationwide distribution to 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, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY. International distribution to Canada, Chile, France, Germany, Greece, Hong Kong, Ireland, Italy, Oman, Philippines, Poland, Saudi Arabia, South Africa, Spain, Taiwan, Turkey, United Arab Emirates, United Kingdom.

    Quantity

    51,250 units