Events

Recall of EXACTA EXTERNAL AND MONITORING DRAINAGE SET

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MEDTRONIC NEUROSURGERY (PS MEDICAL).

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
    83239
  • Event Risk Class
    II
  • Event Initiated Date
    2000-06-26
  • 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
    The sterile barrier may have been compromised.

Device

EXACTA EXTERNAL AND MONITORING DRAINAGE SET
  • Model / Serial
    Model Catalog: 46700 (Lot serial: T0419 T1262 T1974 T2528); Model Catalog: 46700 (Lot serial: T2645 T3237 T3515 T4771); Model Catalog: 46700 (Lot serial: R5652 R5657 R8515 R9938); Model Catalog: 46700 (Lot serial: T5140.)
  • Product Description
    EXACTA DRAINAGE SYSTEM (EXTERNAL)
  • Manufacturer
    MEDTRONIC NEUROSURGERY (PS MEDICAL)

Manufacturer

MEDTRONIC NEUROSURGERY (PS MEDICAL)
  • Manufacturer Address
    GOLETA
  • Source
    HC