BEUDAMED
    FDA Enforcement Class II Terminated

    Phoenix AST-s Indicator, Catalog Number 246009

    Recall: Z-0933-2019 · Reported March 6, 2019

    Enforcement

    Recall Number
    Z-0933-2019
    Event ID
    81952
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton Dickinson & Co.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 6, 2019
    Initiation Date
    December 20, 2018
    Classification Date
    February 23, 2019
    Termination Date
    April 10, 2020
    Address
    7 Loveton Cir, Sparks, MD, 21152-9212, United States

    Description

    Phoenix AST-s Indicator, Catalog Number 246009

    Reason

    Panels inoculated using certain lots of the indicator solution are demonstrating an increased occurrence of test aborts.

    Code Info

    Batch Numbers 8298797 8254819 8254817 8247760 8247750 8206530 8194853 8156642 8156638 8131658 8103973 8094595 8023542 7354942 7300813

    Distribution

    The products were distributed to the following US states: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY. The products were distributed to the following foreign countries: Argentina, Australia, Bangladesh, Belgium, Brazil, Canada, Cayman Islands, Chile, China, Columbia, Costa Rica, Dominican Republic, Ecuador, Guatemala, India, Indonesia, Japan, Korea, Malaysia, Mexico, Myanmar, New Zealand, Pakistan, Panama, Peru, Philippines, San Salvador, Singapore, Sri Lanka, Thailand, Taiwan, Uruguay, Vietnam

    Quantity

    62880 total