Events

Recall of EXACTA-MIX EVA CONTAINER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BAXTER HEALTHCARE CORPORATION A DIVISION OF BAXTER INTERNATIONAL 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
    151902
  • Event Risk Class
    II
  • Event Initiated Date
    2009-12-10
  • 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
    Complaints were received for gross leaks or disengaging of the administration port of multiple lots of exactamix bags. product testing revealed that an intermittent automatic manufacturing problem resulted in mis-assembly of the center port. the solvent (cyclohexanone) used to fuse the port assembly to the bag was missed or inadequately applied.

Device

EXACTA-MIX EVA CONTAINER
  • Model / Serial
    Model Catalog: 738 (Lot serial: 735020); Model Catalog: 739 (Lot serial: 735020); Model Catalog: 739 (Lot serial: 738254); Model Catalog: 738 (Lot serial: 738254); Model Catalog: 740 (Lot serial: 738176); Model Catalog: 739 (Lot serial: 738176); Model Catalog: 738 (Lot serial: 738176); Model Catalog: 740 (Lot serial: 738175); Model Catalog: 739 (Lot serial: 738175); Model Catalog: 738 (Lot serial: 738175); Model Catalog: 740 (Lot serial: 736780); Model Catalog: 739 (Lot serial: 736780); Model Catalog: 738 (Lot serial: 736780); Model Catalog: 740 (Lot serial: 736779); Model Catalog: 739 (Lot serial: 736779); Model Catalog: 738 (Lot serial: 736779); Model Catalog: 740 (Lot serial: 738392); Model Catalog: 739 (Lot serial: 738392); Model Catalog: 738 (Lot serial: 738392); Model Catalog: 740 (Lot serial: 738391); Model Catalog: 739 (Lot serial: 738391); Model Catalog: 738 (Lot serial: 738391); Model Catalog: 740 (Lot serial: 738007); Model Catalog: 739 (Lot serial: 738007); Model Catalog: 738 (Lot serial: 738007)
  • Product Description
    EXACTAMIX EMPTY EVA CONTAINER
  • Manufacturer
    BAXTER HEALTHCARE CORPORATION A DIVISION OF BAXTER INTERNATIONAL INC.

Manufacturer

BAXTER HEALTHCARE CORPORATION A DIVISION OF BAXTER INTERNATIONAL INC.