Events

Safety Alert for Merit 7F Prelude Short Sheath Introducers

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
    2017-03-31
  • Event Date Posted
    2017-03-31
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170331.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 7f prelude short sheath introducers the united states food and drug administration (fda) has issued a medical device safety alert concerning merit 7f prelude short sheath introducers [lot numbers: h1041469, h1041473, h1036880, h1041464; catalogue numbers: k15-00070, k15-00170, pss-7f-4-035mt, pss-7f-4mt; manufacturing dates: 23 nov 2016 to 30 nov 2016; distribution dates: 15 dec 2016 to 18 jan 2017], manufactured by merit medical systems, inc. the manufacturer is recalling the prelude short sheath introducer due to a manufacturing defect which may cause the tip to separate from the sheath during the insertion procedure. if this occurs, the tip could enter the patient's bloodstream. this may result in prolonged procedure times, additional surgery to remove the tip from the patient, blood clots, internal tears and perforation to arteries or veins, excessive bleeding, and death. the manufacturer advises users to quarantine and discontinue use of the affected products and return them to the manufacturer. for details, please refer to the fda website: https://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm549795.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 31 march 2017.

Device

Merit 7F Prelude Short Sheath Introducers
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Merit 7F Prelude Short Sheath Introducers
  • Manufacturer
    Merit Medical Systems

Manufacturer

Merit Medical Systems