BEUDAMED
    FDA Enforcement Class II Terminated

    BBL Port A Cul tubes with Swabs Sterile Pack, catalog number 221607. For patient sample collection.

    Recall: Z-1747-2015 · Reported June 17, 2015

    Enforcement

    Recall Number
    Z-1747-2015
    Event ID
    69954
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton Dickinson & Co.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 17, 2015
    Initiation Date
    November 21, 2014
    Classification Date
    June 10, 2015
    Termination Date
    January 7, 2016
    Address
    BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD, 21152-0999, United States

    Description

    BBL Port A Cul tubes with Swabs Sterile Pack, catalog number 221607. For patient sample collection.

    Reason

    The products may exhibit indications of excessive oxidation. Excessive oxidation may affect the viability of anaerobic microorganisms.

    Code Info

    Part/Cat No. Lot / Serial No.Date of Mfr Exp. Date 221607 4067181 3/19/2014 3/5/2015 221607 4083274 4/3/2014 3/20/2015 221607 4124706 5/9/2014 4/24/2015 221607 4127564 5/22/2014 5/1/2015 221607 4170891 7/8/2014 6/19/2015 221607 4006235 2/18/2014 12/26/2014 221607 4028420 2/19/2014 1/21/2015

    Distribution

    US Nationwide distribution in AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.

    Quantity

    92,710 units