Events

Recall of MEDALLION SERIES CONTROL SYRINGE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MERIT MEDICAL CANADA LTD..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    35215
  • Event Risk Class
    II
  • Event Initiated Date
    2018-02-08
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Merit medical systems inc. is voluntarily conducting a recall of specific lots of 1 ml medallion syringes due to a supplier manufacturing defect with the syringe plunger tip. 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.

Device

MEDALLION SERIES CONTROL SYRINGE
  • Model / Serial
    Model Catalog: MSS011-YP (Lot serial: > 10 numbers contact mfg.); Model Catalog: K01-05526P (Lot serial: > 10 numbers contact mfg.); Model Catalog: MSS011-R (Lot serial: > 10 numbers contact mfg.); Model Catalog: MSS011-PR (Lot serial: > 10 numbers contact mfg.); Model Catalog: MSS011-LG (Lot serial: > 10 numbers contact mfg.); Model Catalog: MSS011-DG (Lot serial: > 10 numbers contact mfg.); Model Catalog: MSS011 (Lot serial: > 10 numbers contact mfg.); Model Catalog: K12-03636 (Lot serial: > 10 numbers contact mfg.); Model Catalog: K04-00748 (Lot serial: > 10 numbers contact mfg.); Model Catalog: K02-01331A (Lot serial: > 10 numbers contact mfg.); Model Catalog: K02-01260B (Lot serial: > 10 numbers contact mfg.); Model Catalog: K02-00565C (Lot serial: > 10 numbers contact mfg.); Model Catalog: K01-07930P (Lot serial: > 10 numbers contact mfg.); Model Catalog: K01-07477P (Lot serial: > 10 numbers contact mfg.); Model Catalog: K01-07427 (Lot serial: > 10 numbers contact mfg.); Model Catalog: MSS011-Y (Lot se
  • Product Description
    1 ML MEDALLION SYRINGE
  • Manufacturer
    MERIT MEDICAL CANADA LTD.

Manufacturer

MERIT MEDICAL CANADA LTD.