Events

Recall of EMPTY EVACUATED GLASS CONTAINER WITH VACUUM - VACUUM COLLECTION UNIT

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
    32361
  • Event Risk Class
    III
  • Event Initiated Date
    2010-02-24
  • 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 stability testing an out of specification ph was found prior to the 12 month expiry date in the various product code glass bottles.

Device

EMPTY EVACUATED GLASS CONTAINER WITH VACUUM - VACUUM COLLECTION UNIT
  • Model / Serial
    Model Catalog: 1A8503 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 1A8502 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 1A8504 (Lot serial: >10 NUMBERS CONTACT MFR)
  • Product Description
    EVACUATED CONTAINERS
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION