Events

Recall of VACUETTE BLOOD COLLECTION SET

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by FISHER SCIENTIFIC.

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
    22782
  • Event Risk Class
    III
  • Event Initiated Date
    2013-04-03
  • 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
    Products may have a small crack at the luer connector. this defect may cause minor leakage (small droplets) of blood or infusion liquid at the luer connector site. collection tubes would only fill with a few droplets or would not fill at all.

Device

VACUETTE BLOOD COLLECTION SET
  • Model / Serial
    Model Catalog: 450096 (Lot serial: 12H24); Model Catalog: 450096 (Lot serial: cat 22 040 138); Model Catalog: 450096 (Lot serial: 12H23); Model Catalog: 450096 (Lot serial: lot 12H22)
  • Product Description
    safety blood collection sets with luer
  • Manufacturer
    FISHER SCIENTIFIC

Manufacturer

FISHER SCIENTIFIC