Events

Safety Alert for custom procedural trays or kits containing 1% Lidocaine HCl Injection

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

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
    2014-02-27
  • Event Date Posted
    2014-02-27
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140227.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: merit medical systems custom procedural trays or kits containing 1% lidocaine hcl injection the u.S. food and drug administration (fda) posted a medical device safety alert concerning custom procedural trays or kits containing 1% lidocaine hcl injection, usp, 10 mg/ml, lot 25-090-dk. the products were recalled because there was one confirmed customer report where visible particulate were found in the primary product container in the form of dark red/black particles. the particular matter may dislodge through the tissue and could possibly cause a pneumothorax or haemothorax. for details, please refer to the fda website http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-product-tabs.Cfm?action=select&recall_number=z-0980-2014&w=02262014&lang=eng if you are in possession of the product, please contact your supplier for necessary actions. posted on 27 february 2014.

Device

custom procedural trays or kits containing 1% Lidocaine HCl Injection

Manufacturer

Merit Medical Systems