Events

Recall of INTELLIFLO DRESSING

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Breg Inc, An Orthofix Company.

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
    58247
  • Event Risk Class
    Class 2
  • Event Number
    Z-2326-2012
  • Event Initiated Date
    2010-08-11
  • Event Date Posted
    2012-09-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98803
  • 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
    Tape and bandage, adhesive - Product Code KGX
  • Reason
    This recall has been initiated due to confirmation that the polar dressing, knee/mu/shldr intelli-flo-breg does not meet the required thickness as specified. the dressing in the sterile pouch measures a thickness of 0.010" instead of 0.020". this change in thickness makes the dressing thinner, less durable and subject to tearing. the product is mislabeled.
  • Action
    The firm, Breg Orthofix, called their customers on August 11, 2010 sent a letter dated August 12, 2010 and emails to all customers. The call and letter described the product, problem and actions to be taken. The customers were instructed to take immediate action to identify and quarantine the product at their facility. Breg established a return materials authorization and is contacting their customers to provide a Return Authorization to return the dressings. Breg is also providing replacement dressings. If you have any questions regarding communication or the Intelli-Flo Sterile Dressing, contact Breg Customer Relations at (800) 321-0607.

Device

INTELLIFLO DRESSING
  • Model / Serial
    Lot # D101564
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and country of: Nova Scotia.
  • Product Description
    Polar Dressing, Knee/MU/Shldr Intelli-Flo-Breg, PN 10630 || Used with cold therapy pads to provide insulation barrier between the pad and patient's skin.
  • Manufacturer
    Breg Inc, An Orthofix Company

Manufacturer

Breg Inc, An Orthofix Company