Events

Recall of VACUTAINER BRAND PRESET KIT

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
    20295
  • Event Risk Class
    III
  • Event Initiated Date
    2016-12-29
  • 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 reports of safety cover disengagement and needlestick injury (nsi) for the bd eclipse needle. based on the customer reports in some cases when the safety cover is pushed over the needle it disengages resulting in an exposed needle which can increase the risk of nsi. some customer reports indicate an audible "click" sound before the safety cover is locked (activated) followed by a second "click" sound when the safety cover is locked over the needle. this may potentially increase the risk of nsi if the user assumes the safety cover is locked after the initial "click". bd advises customers to be aware of this matter and follow the instructions for use (ifu) to: "center your thumb or forefinger on the textured finger pad and push the safety cover forward over the needle until you hear or feel it lock. visually confirm that the needle is covered.".

Device

VACUTAINER BRAND PRESET KIT
  • Model / Serial
    Model Catalog: 364390 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 364391 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 305786 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 305785 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 305784 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 305783 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 305782 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 305781 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 305780 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 305779 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 305778 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 305768 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 305767 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 305766 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 305765 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 305764 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 305763 (Lot serial: >10 NUMBERS
  • Product Description
    BD ECLIPSE NEEDLE (DEVICE LICENCE #788);BD ECLIPSE NEEDLE (DEVICE LICENCE #61367)
  • Manufacturer
    BECTON DICKINSON CANADA INC.

Manufacturer

BECTON DICKINSON CANADA INC.