Events

Recall of Acumedia Sabouraud Dextrose Agar w /Lecithin and Tween 20

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
    77281
  • Event Risk Class
    Class 3
  • Event Number
    Z-2212-2017
  • Event Initiated Date
    2016-08-08
  • 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=155600
  • 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
    Culture media, non-selective and non-differential - Product Code JSG
  • Reason
    Storage temperature listed on the label was incorrect. label stated 2-30¿c. actual storage temperature is 2-8¿c.
  • Action
    On 8/8/2016 and 10/6/2016, 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 Sabouraud Dextrose Agar w /Lecithin and Tween 20
  • Model / Serial
    PN 91081C, Lot 108367A PN 91081C, Lot 107632A
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US in the state of IL
  • Product Description
    Sabouraud Dextrose Agar w /Lecithin and Tween 20 || Acumedia PN 91081 || Product Usage: || Used for the isolation of fungi from surfaces sanitized with quaternary ammonium compounds
  • Manufacturer
    Acumedia Manufacturers, Inc.

Manufacturer

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