BEUDAMED
    FDA Enforcement Class II Terminated

    60" (152 cm) Appx 1.0 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, NanoClave, 0.2 Micron Filter, 1.2 Micron Filter, 4 Clamps (2 Blue, Yellow, White), Rotating Luer; 1 unit per pouch, 50 multivac pouches per case UDI:(01)10887709083889(17)241201(30)50(10)4514845; (01)10887709083889(17)250101(30)50(10)4549102; (01)10887709083889(17)250201(30)50(10)4730714. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein).

    Recall: Z-0206-2021 · Reported October 28, 2020

    Enforcement

    Recall Number
    Z-0206-2021
    Event ID
    86054
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ICU Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 28, 2020
    Initiation Date
    July 6, 2020
    Classification Date
    October 22, 2020
    Termination Date
    May 11, 2023
    Address
    951 Calle Amanecer, N/A, San Clemente, CA, 92673-6212, United States

    Description

    60" (152 cm) Appx 1.0 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, NanoClave, 0.2 Micron Filter, 1.2 Micron Filter, 4 Clamps (2 Blue, Yellow, White), Rotating Luer; 1 unit per pouch, 50 multivac pouches per case UDI:(01)10887709083889(17)241201(30)50(10)4514845; (01)10887709083889(17)250101(30)50(10)4549102; (01)10887709083889(17)250201(30)50(10)4730714. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein).

    Reason

    Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.

    Code Info

    Lot Number:4514845, 4549102, 4730714.

    Distribution

    Worldwide Distribution: US (nationwide): AL, AZ, CA, CO, DE, FL,GA,ID, IL,IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH,NJ,NM,NV, NY, OH, OK, OR, PA,RI, TN, TX, UT, VA, WA, WI, and WV; and OUS countries of: Belgium, Brazil, Canada, France, Germany, Ireland, Japan, Martinique, Mexico, Poland, and Saudi Arabia.

    Quantity

    Total of all products (Listed #1 thru 101) = 304735 units