Events

Safety Alert for Merit 1mL Medallion Syringes

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
    2018-03-05
  • Event Date Posted
    2018-03-05
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180305.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 1ml medallion syringes medical device manufacturer, merit medical systems, inc., has issued a medical device safety alert concerning its 1ml medallion syringes. the affected products are identified as below: catalog numbers: a) k01-05526p; b) k01-07427; c) k01-07477p; d) k01-07930p; e) k02-00565c; f) k02-01260b; g) k02-01331a; h) k04-00748; i) k12-03636; j) mss011; k) mss011-dg; l) mss011-lg; m) mss011-pr; n) mss011-r; o) mss011-y; p) mss011-yp. lot numbers: a) h1258821; b) h1263015; c) h1242962, h1246807; d) h1246733; e) h1258361; f) h1258575, h1265248; g) h1252652; h) h1258488, h1264381; i) h1258530; j) h1242750, h1246807, h1255504; k) h1246809; l) h1246810; m) h1242752; n) h1242752, h1255507; o) h1246811; p) h1242927. the manufacturer is voluntarily conducting a recall of specific lots of 1 ml medallion syringes due to a supplier manufacturing defect with the syringe plunger tip. according to the manufacturer, prior to use and during prep, when fluid is drawn into the syringe, air may enter the barrel and/or fluid may leak out the back of the barrel. this may result in a minor delay in procedure and user dissatisfaction. it has not received any reports of patient harm or injury as a result of this issue. the manufacturer has chosen to remove the units from the market. according to the local supplier, the affected products are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 5 march 2018.

Device

Merit 1mL Medallion Syringes
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Merit 1mL Medallion Syringes
  • Manufacturer
    Merit Medical Systems

Manufacturer

Merit Medical Systems