BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1747-2015 · Initiated November 21, 2014

    Recall

    Recall Number
    Z-1747-2015
    Event Number
    69954
    Firm
    Becton Dickinson & Co. BD Diagnostic Systems
    FEI Number
    1119779
    Product Code
    N/A
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 21, 2014
    Posted
    June 10, 2015
    Terminated
    January 7, 2016
    Address
    7 Loveton Circle, Sparks, MD, 21152-0999

    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.

    Action

    BD Diagnostic Systems sent an Urgent Product Recall letter dated December 2014 to all affected customers. Recall notification was initiated on November 21, 2014, the notification was sent by fax and letters by UPS. Customer notification for the expansion of the recall was initiated on December 18, 2014, the notification was sent by fax and letters by UPS. For questions regarding this recall call 800-638-8663.

    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