Events

Recall of 3M Attest

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

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
    27465
  • Event Risk Class
    Class 2
  • Event Number
    Z-0237-04
  • Event Initiated Date
    2003-10-24
  • Event Date Posted
    2003-12-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-02-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30057
  • 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
    The 3m attest 1264/1264p biological indicators of eto sterilization contain a microbiological contaminant which can affect the performance of the positive control and the indicators to some limited extent. the color on a positive control may revert to negative after 24 hours of incubation.
  • Action
    The firm conducted a field correction which began on 10/24/03. They provided revised labeling for the product. Letters, dated October 24, 2003, were sent to consignees. The letters had a description of the problem, instructions for doing the relabeling in the field, and recommendations for users of the product.

Device

3M Attest
  • Model / Serial
    Lot numbers 2005-07 DW, 2005-08 DD, and 2005-08 DL
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was distributed nationwide in the United States and worldwide.
  • Product Description
    3M Attest 1264P Biological Indicators, in boxes of 25 per box
  • Manufacturer
    3m Health Care

Manufacturer

3m Health Care
  • Manufacturer Address
    3m Health Care, 3m Center, Saint Paul MN 55144-1001
  • Source
    USFDA