Events

Recall of Device Recall Acumedia Nutrient Gelatin

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
    77275
  • Event Risk Class
    Class 3
  • Event Number
    Z-2213-2017
  • Event Initiated Date
    2016-03-23
  • 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=155595
  • 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
    Incorrect expiration date was listed on the label. correct expiration date was november 30, 2016. product was labeled with expiration date of april 30, 2018.
  • Action
    On 3/23/2016, 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

Device Recall Acumedia Nutrient Gelatin
  • Model / Serial
    PN 7471A, Lot 105550F
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide - US Nationwide in the state of ME; in the country of ECUADOR
  • Product Description
    Nutrient Gelatin, Acumedia Part Number 7471 A || Product Usage: || Nutrient Gelatin is used for the differentiation of microorganisms on the basis of gelatinase production. Identifying fermentative and non-fermentative Gram-negative bacilli include testing for gelatin liquefaction. If the proteolytic enzyme gelatinase is present, gelatin is hydrolyzed and loses its gelling characteristic.
  • Manufacturer
    Acumedia Manufacturers, Inc.

Manufacturer

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