BEUDAMED
    FDA Enforcement Class II Ongoing

    REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 mm 64 mL/min , Rx Only, Sterile EO

    Recall: Z-0025-2024 · Reported October 11, 2023

    Enforcement

    Recall Number
    Z-0025-2024
    Event ID
    92970
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Becton Dickinson Infusion Therapy Systems Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 11, 2023
    Initiation Date
    August 29, 2023
    Classification Date
    October 3, 2023
    Address
    9450 S State St, N/A, Sandy, UT, 84070-3213, United States

    Description

    REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 mm 64 mL/min , Rx Only, Sterile EO

    Reason

    There is the potential that the safety shield may not properly engage on IV catheters. The needle can pull through the safety shield and disconnect from the needle safety shield leaving the contaminated needle point exposed.

    Code Info

    Lot # 2238464/ UDI-DI: (01)00382903868629

    Distribution

    US Nationwide distribution in the states of CA, FL, GA, MA, MN, MO, MS, NJ, OH, TX.

    Quantity

    98,000 units