Events

Safety Alert for EXACTAMIX Inlets

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Baxter Healthcare.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2018-05-07
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180507c.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: baxter healthcare exactamix inlets medical device manufacturer, baxter healthcare, has issued a medical device safety alert concerning its exactamix inlets, details of product are identified as below: exactamix inlet. non-vented, high-volume inlet; product code: h938173; lot number (corrected expiration date) 802278 (9/2018), 802383 (10/2018), 802385 (5/2018) exactamix inlet. vented, high-volume inlet; product code: h938174; lot number (corrected expiration date): 802279 (8/2018), 802280 (8/2018) exactamix inlet. syringe inlet; product code: h938176; lot number (corrected expiration date) 802286 (9/2018) the manufacturer is issuing a voluntary product recall for the above lots due to incorrectly performed over-labeling. the inlets were over-labeled with a blank label, or with a label containing an extended expiration date. according to the manufacturer, the use of an affected inlet that may have lost its sterility due to being used past its actual expiration date may result in a bloodstream infection or other serious adverse health consequences. the customers are required to locate and remove all affected product lots from their facility. according to the local supplier, there are no serious injury and adverse event reported in hong kong. the affected products are distributed in hong kong between 2 june 2017 and 15 february 2018. if you are in possession of the products, please contact your supplier for necessary actions. updated on 10 may 2018.

Device

EXACTAMIX Inlets
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Baxter Healthcare EXACTAMIX Inlets
  • Manufacturer
    Baxter Healthcare

Manufacturer

Baxter Healthcare