Events

Recall of Device Recall BD BBL Vancomycin Screen Agar

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Becton Dickinson & Co..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    69062
  • Event Risk Class
    Class 2
  • Event Number
    Z-2628-2014
  • Event Initiated Date
    2014-07-28
  • Event Date Posted
    2014-09-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-01-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129481
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Manual antimicrobial susceptibility test systems - Product Code JWY
  • Reason
    These lots of agar may have exhibited breakthrough growth of vancomycin susceptible enterococcus species control organisms. agar that allows susceptible enterococci to grow appears as a falsely resistant culture. if a lab does not qc, the error would be identified as falsely resistant enterococci would have further ast workup. there could be a delay in the identification of false-resistance.
  • Action
    BD Diagnostic System sent an Urgent Product Recall letter dated July 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Our records indicate you may have been shipped the above-referenced lot numbers of product between March 5, 2014 and June 5, 2014. Please discontinue use of these lot numbers and discard any remaining packages. If further assistance is needed, please contact BD Technical Services Department at 1-800-638-8663. The acknowledgement form included with the follow up letter that is faxed back to BD will be reconciled with the customer list. BD will contact 10% of non-respondents to verify receipt of the customer letter. BD has asked distributors to send their customer list to BD for follow up.

Device

Device Recall BD BBL Vancomycin Screen Agar
  • Model / Serial
    Lot numbers -  4080291 4042217 4048040 4052349 4058242 4073274 4127728
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (Nationwide) including the states of 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, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI and WV; and Internationally to the countries of Belgium, Canada, Colombia, India, Mexico, Singapore and Taiwan.
  • Product Description
    BD BBL Vancomycin Screen Agar Catalog number 222204 || Vancomycin Screen Agar is used to test enterococci for resistance to vancomycin and to predict the synergistic activity of this antimicrobial with an aminoglycoside antimicrobial.
  • Manufacturer
    Becton Dickinson & Co.

Manufacturer

Becton Dickinson & Co.
  • Manufacturer Address
    Becton Dickinson & Co., 7 Loveton Cir, BD Diagnostic Systems, Sparks MD 21152-9212
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA