Events

Recall of BLOOD IV SOLUTION SET

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
    36944
  • Event Risk Class
    II
  • Event Initiated Date
    2010-01-08
  • 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
    During product inspection of y-type blood solution sets baxter observed that some blood filter devices contained fiber-like particulate matter consistent with filter material in the fluid path below the filter.

Device

BLOOD IV SOLUTION SET
  • Model / Serial
    Model Catalog: JC8750 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: JC7751 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: JC7627C (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: JC6392 (Lot serial: >10 NUMBERS CONTACT MFR)
  • Product Description
    Y-TYPE BLOOD SOLUTION SETS
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION