Events

Safety Alert for Irrigation Sets [Product Codes: 2C4013 & 2C4030]

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

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
    2013-05-14
  • Event Date Posted
    2013-05-14
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130514.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 irrigation sets [product codes: 2c4013 & 2c4030] medical device manufacturer, baxter healthcare ltd, has issued a medical device safety alert concerning the irrigation sets [product codes: 2c4013 & 2c4030]. the product description and lot numbers affected are detailed as below:- 2c4013—four lead tur irrigation set for use with uromatic plastic containers all lot starting with ur171264 to ur385534 and starting with ur07j19029 to ur13c08036 2c4030—two lead arthroscopic irrigation set for user with arthromatic plastic containers, all lots starting with r06k01083 to r12fo9087. the manufacturer is issuing a voluntary recall for the irrigation sets listed above. an internal investigation led to discovery of pinhole defects in the packaging of the two codes listed above. these pinholes are not likely to be detected by the end user prior to use. pinholes could compromise the sterile barrier properties of the packaging. a potential outcome of a breach in sterile packaging is contamination of the surgical field, which may lead to patient infection. the manufacturer requests users to immediately locate, segregate and discontinue use of the affected products. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 14 may 2013.

Device

Irrigation Sets [Product Codes: 2C4013 & 2C4030]
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Baxter Healthcare Irrigation Sets [Product Codes
  • Manufacturer
    Baxter Healthcare Ltd

Manufacturer

Baxter Healthcare Ltd