Events

Recall of Device Recall 3M AttestTM Autoreader

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by 3M Company - Health Care Business.

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
    68415
  • Event Risk Class
    Class 2
  • Event Number
    Z-2002-2014
  • Event Initiated Date
    2014-06-09
  • Event Date Posted
    2014-07-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-06-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127541
  • 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
    Indicator, biological sterilization process - Product Code FRC
  • Reason
    Labeling on units shipped prior to may 16th, 2014 did not contain the statement "this product contains dry natural rubber" as required by the united states food and drug administration (fda) for medical devices. the non-slip pads at the bottom of the unit contain dry natural rubber. one incident of an allergic reaction in a sensitized individual has been reported.
  • Action
    Consignees were sent on 6/9/2014 a 3M "Urgent Medical Devices Correction" letter dated May 21, 2014. The letter described the problem and the product involved in the recall. The letter described what action is 3M taking and what action was required of the consignees. Consignees were sent an adhesive label and a response card. They requested consignees to adhere the label to a portion of the plastic covering each unit in a location where it is visible to the end-user. After that, they are requested to fill out and return the response card.

Device

Device Recall 3M AttestTM Autoreader
  • Model / Serial
    All serial numbers.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the countries of AUSTRALIA, CANADA, CHILE , COLOMBIA, COSTA RICA, SOUTH AFRICA, BRAZIL, GERMANY, ECUADOR, DUBAI, JAPAN, HONG KONG , CHINA, KOREA, MALAYSIA, PANAMA, SINGAPORE, VATICAN, and THAILAND.
  • Product Description
    3M Attest Auto-reader. Model numbers 390, 390G,and 490. || These devices incubate the biological indicators (BIs) to determine a positive or negative result for the sterilization cycle.
  • Manufacturer
    3M Company - Health Care Business

Manufacturer

3M Company - Health Care Business
  • Manufacturer Address
    3M Company - Health Care Business, 3M Center 2510 Conway Ave , B# 275-5-W-6, Saint Paul MN 55144
  • Manufacturer Parent Company (2017)
    3m Company
  • Source
    USFDA