Events

Recall of VIAFLEX CONTAINER EMPTY

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BAXTER CORPORATION.

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
    15397
  • Event Risk Class
    II
  • Event Initiated Date
    2017-07-31
  • 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
    Baxter is issuing a recall for a specific product code and lot number due to the potential presence of leaks. a leak may allow for microbial contamination of the sterile fluid path. if not detected the use of a bag with leak could lead to a bloodstream infection or other serious adverse health consequences. there have been no reports of adverse events associated with this issue for leaks.

Device

VIAFLEX CONTAINER EMPTY
  • Model / Serial
    Model Catalog: 2J8003 (Lot serial: DR16J18096)
  • Product Description
    EMPTY INTRAVIA CONTAINER
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION