Events

Recall of Device Recall BBL Enterococcus Screen Agar QUAD Plate

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
    71883
  • Event Risk Class
    Class 2
  • Event Number
    Z-0474-2016
  • Event Initiated Date
    2015-06-29
  • Event Date Posted
    2015-12-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139272
  • 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
    The affected expired lots of product may have exhibited breakthrough growth of vancomycin susceptible enterococcus facaelis atcc 29212 near the end of shelf life. the in-date product may also exhibit breakthrough growth of vancomycin susceptible enterococcus facaelis atcc 29212 near the end of shelf life.
  • Action
    Becton Dickinson (BD) sent US customers a Urgent Product Recall letter dated June 2015, via UPS. Customers were requested to return response forms indicating acknowledgement of the recall and quantity of remaining product that was at their facility. 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. Any product returned to BD will be quarantined and discarded. If further assistance is needed, please contact BD Technical Services at 1-800-638-8663.

Device

Device Recall BBL Enterococcus Screen Agar QUAD Plate
  • Model / Serial
    catalog number 222201.  Lot numbers 5064938, 5085954, 5105509, and 5133580
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) Distribution to the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, WI and WV., and to the countries of : Canada, Colombia, India, Mexico and Europe.
  • Product Description
    Enterococcus Screen Agar QUAD Plate
  • Manufacturer
    Becton Dickinson & Co.

Manufacturer

Becton Dickinson & Co.
  • Manufacturer Address
    Becton Dickinson & Co., BD Diagnostic Systems, 7 Loveton Circle, Sparks MD 21152-0999
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA