BEUDAMED
    FDA Recall Terminated

    REF MC330209 6' (15 cm) Appx 0.09 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 0.2 Micron Filter, 1.2 Micron Filter, 3 Clamps (Blue, Yellow, White), Rotating Luer - Product Usage: 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 catheter (which is inserted into a vein). Directions for Use: icumedical IV Extension Sets Clave/MicroClave/NanoClave Connectors Antimicrobial Clave/MicroClave Connectors Spiros Closed Male Luer.

    Recall: Z-0511-2021 · Initiated July 1, 2020

    Recall

    Recall Number
    Z-0511-2021
    Event Number
    86075
    Firm
    ICU Medical, Inc.
    FEI Number
    2025816
    Product Code
    FMG
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    July 1, 2020
    Terminated
    December 1, 2022
    Address
    951 Calle, Amanecer San Clemente, CA, 92673-6212

    Description

    REF MC330209 6' (15 cm) Appx 0.09 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 0.2 Micron Filter, 1.2 Micron Filter, 3 Clamps (Blue, Yellow, White), Rotating Luer - Product Usage: 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 catheter (which is inserted into a vein). Directions for Use: icumedical IV Extension Sets Clave/MicroClave/NanoClave Connectors Antimicrobial Clave/MicroClave Connectors Spiros Closed Male Luer.

    Reason

    Incorrect filter assemblies in IV administration set.

    Action

    On 07/01/2020, the firm sent an Urgent: Medical Device Recall" to customers via mail, by third party to inform them that the firm has become aware that there is a potential problem related to the IV administration set with incorrect filter, which may result in delay in therapy, contamination or particulate embolism. This recall affected specific lots. The firm is instructing customers to discontinue the use, distribution and quarantine the products, print the return label from http://expertezlabel.com and return the affected devices to third party contracted service and if questions, to contact [email protected] or 1-844-654-7780 for adverse event or complaints and for additional assistance, to call 1-866-829-9025, option 8 or [email protected]. .

    Distribution

    U.S. Nationwide distribution including in the states of WI, MA, CA, FL, MN, IL, NY.

    Quantity

    1100 units