BEUDAMED
    FDA Enforcement Class II Ongoing

    B. Braun Introcan IV Safety Catheters, sterile - Product Usage: It is a single-use device to generate intravascular and tissue access to sample blood, monitor blood pressure, or administer fluids and blood intravascular.

    Recall: Z-0930-2021 · Reported February 3, 2021

    Enforcement

    Recall Number
    Z-0930-2021
    Event ID
    86443
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Braxton Medical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 3, 2021
    Initiation Date
    September 4, 2020
    Classification Date
    January 27, 2021
    Address
    15402 N Nebraska Ave Ste 204, Lutz, FL, 33549-6149, United States

    Description

    B. Braun Introcan IV Safety Catheters, sterile - Product Usage: It is a single-use device to generate intravascular and tissue access to sample blood, monitor blood pressure, or administer fluids and blood intravascular.

    Reason

    Recalled products do not have FDA approval for sale in the United States.

    Code Info

    All lot numbers under item codes ending in -01: 4251601-01, 4251628-01, 4251652-01, 4251687-01, 4251890-01, 4252500-01, 4252519-01, 4252527-01, 4252535-01, 4252543-01, 4252560-01, 4252586-01, 4252594-01, 4253523-01, 4253540-01, 4254546-01.

    Distribution

    US Nationwide distribution including in the states of AL, CA, CT, FL, GA, IL, KS, LA, MI, MN, NC, NJ, NY, PA, SD, TX, WA.

    Quantity

    1,781 cases