Events

Recall of Acumedia Beef Extract Powder

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Acumedia Manufacturers, Inc..

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
    77272
  • Event Risk Class
    Class 3
  • Event Number
    Z-2214-2017
  • Event Initiated Date
    2015-09-11
  • Event Date Posted
    2017-06-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-06-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155592
  • 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
    Supplement, culture media - Product Code JSK
  • Reason
    Incorrect expiration date on label. correct expiration date was march 25, 2019. product was labeled with expiration date of march 28,2019.
  • Action
    On 9/11/2015, notifications were sent to the affected consignees via e-mail. The recall notification included a description of the reason for the recall, affected product, and information for the correction to product.

Device

Acumedia Beef Extract Powder
  • Model / Serial
    PN 7228, Lot 107984A
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide - US Nationwide in the state IL and the country of COLOMBIA
  • Product Description
    Beef Extract Powder, Acumedia PN 7228 || Product Usage: || Beef Extract Powder is prepared and standardized for use in microbiological culture media, where it is generally used to replace infusion of meat. Culture media containing Beef Extract Powder are recommended for use in bacteriological examination of water, milk, and other materials, where uniform composition of media is important. Beef Extract Powder is relied upon for biochemical studies, particularly fermentation reactions because of its independence from ferment-able substances. Several media containing Beef Extract Powder are recommended in standard methods for multiple application.
  • Manufacturer
    Acumedia Manufacturers, Inc.

Manufacturer

Acumedia Manufacturers, Inc.
  • Manufacturer Address
    Acumedia Manufacturers, Inc., 740 E Shiawassee St, Lansing MI 48912-1218
  • Source
    USFDA