BEUDAMED
    FDA Enforcement Class II Terminated

    100" (254 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer w/Filter Cap, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

    Recall: Z-2632-2018 · Reported August 15, 2018

    Enforcement

    Recall Number
    Z-2632-2018
    Event ID
    80427
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ICU Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 15, 2018
    Initiation Date
    July 31, 2017
    Classification Date
    August 7, 2018
    Termination Date
    March 12, 2019
    Address
    951 Calle Amanecer, N/A, San Clemente, CA, 92673-6212, United States

    Description

    100" (254 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer w/Filter Cap, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

    Reason

    Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

    Code Info

    Item Number K098-001, Lot Number 3332425, 3364299, 3396263

    Distribution

    Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.

    Quantity

    160,016 units total