Events

Recall of SYRINGE AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BARD CANADA 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
    62139
  • Event Risk Class
    II
  • Event Initiated Date
    2011-06-22
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    The avitene instructions for use (ifu) have been revised to include a warning or precaution on the possible development of post-operative inflammatory reaction to the device including its clinical features and its timing.

Device

SYRINGE AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT
  • Model / Serial
    Model Catalog: (Lot serial: WBRJFD43); Model Catalog: (Lot serial: >10 NUNBERS CONTACT MFR); Model Catalog: (Lot serial: >10 NUMBERS CONTACT MFR)
  • Product Description
    SYRINE AVITENE MICROFIBRILLAR COLLAGEN
  • Manufacturer
    BARD CANADA INC.

Manufacturer

BARD CANADA INC.