Events

Recall of VIAFLEX CONTAINER WITH CONNECTOR

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
    146124
  • Event Risk Class
    III
  • Event Initiated Date
    2013-11-29
  • 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
    Safety alert communication issued for additional instruction in some cases not included on labeling for viaflex container with connector: do not use flexible solution container if the administration port protector is not in place prior to use. baxter requested customers to not use flexible solution containers if the administration protector is not in place. the port protector serves as a sterility barrier and if port protector missing sterility of administration port may be compromised potentially placing atients at risk of blood stream infection due to microbial contamination introduced to the fluid path. no associated deaths or serious injury related to this issue.

Device

VIAFLEX CONTAINER WITH CONNECTOR
  • Model / Serial
    Model Catalog: JB8086C (Lot serial: >100 numbers contact mfg); Model Catalog: JB8087C (Lot serial: >100 numbers contact mfg); Model Catalog: JB8082C (Lot serial: >100 numbers contact mfg); Model Catalog: JB8084C (Lot serial: >100 numbers contact mfg); Model Catalog: JB8083C (Lot serial: >100 numbers contact mfg)
  • Product Description
    VIAFLEX CONTAINER WITH CONNECTOR
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION