Events

Recall of 3M Ioban

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
    25979
  • Event Risk Class
    Class 2
  • Event Number
    Z-0838-03
  • Event Initiated Date
    2003-04-07
  • Event Date Posted
    2003-05-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-07-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26820
  • 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
    Drape, Surgical - Product Code KKX
  • Reason
    The product did not meet its specifications for iodine content, and had the possibility of causing moderate short-term skin irritation if used.
  • Action
    3M sent Cardinal Health a letter dated April 7, 2003 to provide to their customers. The letter instructed the customers to remove Ioban 2 drapes contained in Cardinal Health packs and use a separately supplied equivalent drape.

Device

3M Ioban
  • Model / Serial
    3M Ioban 2 Antimicrobial Incise Drapes, Model 6648EZ, which were contained in Cardinal Health Custom Procedure Packs sterilized between December 20, 2002 and February 28, 2003, were recalled.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Procedure packs containing the drapes were shipped nationwide in United States.
  • Product Description
    3M Ioban 2 Antimicrobial Incise Drapes, Model 6648EZ
  • Manufacturer
    3m Health Care

Manufacturer

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