Safety Alert for Standard Rigid Tip Suction Wand

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

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
    2012-11-07
  • Event Date Posted
    2012-11-07
  • Event Country
  • Event Source
    DH
  • Event Source URL
  • 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: california medical laboratories standard rigid tip suction wand medical device manufacturer, california medical laboratories, inc. has initiated a field safety corrective action concerning the standard rigid tip suction wand (item no.: su-12202, lot no.: s111480 and s112462). due to insufficient adhesive application, the distal tip has the potential to come loose from the wand and fall into the patient's chest cavity. this would likely be identified during, or prior to, the procedure. if the issue goes unnoticed there is the possibility of risk to the patient should the clinician not remove the detached component and subsequently close the surgical site. the manufacturer is notifying the affected users not to use the affected products and to return any unused product and order replacements. according to conmed limited, the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 7 november 2012.

Device

  • Model / Serial
  • Product Description
    Medical Device Safety Alert: California Medical Laboratories Standard Rigid Tip Suction Wand
  • Manufacturer

Manufacturer