BEUDAMED
    FDA Recall Terminated

    Phoenix AST-s Indicator, Catalog Number 246009

    Recall: Z-0933-2019 · Initiated December 20, 2018

    Recall

    Recall Number
    Z-0933-2019
    Event Number
    81952
    Firm
    Becton Dickinson & Co.
    FEI Number
    1119779
    Product Code
    LON
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    December 20, 2018
    Terminated
    April 10, 2020
    Address
    7 Loveton Cir, Sparks, MD, 21152-9212

    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.

    Action

    Urgent Medical Device Product Advisory letters dated 12/20/18 were sent to customers. Amended Urgent Medical Device Product Advisory letters dated 1/23/19 were also sent to customers.

    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