Events

Recall of EPILOR SYRINGE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BECTON DICKINSON CANADA INC..

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
    100551
  • Event Risk Class
    II
  • Event Initiated Date
    2013-09-06
  • 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
    Bd has received several reports indicating that the plunger of the 7 ml bd epilor plastic bd luer-lok loss of resistance syringe (lor) may stall or stick when travelling within the syringe. this may prevent the user from detecting a loss of resistance upon entering the epidural space. if this occurs the user may continue to advance the syringe and needle through the epidural space and the dura into the spinal canal/intrathecal space resulting in a spinal anesthesia instead of an epidural anesthesia. there have been no reports of harm to patients. date the event was first identified: 06/19/2013. bd has received complaints from customers indicating that product has exhibited higher than normal resistance in the 7ml epilor syringe. there have been a total of 7 complaints for related events in the last 3 fiscal years.

Device

EPILOR SYRINGE
  • Model / Serial
    Model Catalog: 405198 (Lot serial: >10 contact manufacturer); Model Catalog: 405291 (Lot serial: >10 contact manufacturer); Model Catalog: 406078 (Lot serial: >10 contact manufacturer)
  • Product Description
    7 mL BD Epilor plastic BD Luer-Lok LOR Syringe (Bulk non-sterile & sterile single use)
  • Manufacturer
    BECTON DICKINSON CANADA INC.

Manufacturer

BECTON DICKINSON CANADA INC.