BEUDAMED
    FDA Enforcement Class II Completed

    ICU Medical 14" (36 cm) Appx 3.6 ml, Bifuse Transfer Set w/Rotating Luer, REF: 14237-28 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-0069-2019 · Reported October 10, 2018

    Enforcement

    Recall Number
    Z-0069-2019
    Event ID
    80946
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    ICU Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 10, 2018
    Initiation Date
    August 20, 2018
    Classification Date
    October 4, 2018
    Address
    951 Calle Amanecer, San Clemente, CA, 92673-6212, United States

    Description

    ICU Medical 14" (36 cm) Appx 3.6 ml, Bifuse Transfer Set w/Rotating Luer, REF: 14237-28 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

    Design change implemented changing the device from a blood set with a filter to a transfer set without a filter. Both devices had the same listing number. Customers may not be aware of the product design change and use the transfer set as a blood transfusion set without realizing a blood filter is not included.

    Code Info

    lots: 85-540-SJ, 86-189-SL, 86-911-SJ

    Distribution

    U.S. Distribution in states of: NY, AL, CA, MS, PA, GA, MI, NC, WI, IL, WA, UT and FL.

    Quantity

    2361 Units