Events

Recall of ONCONTROL BIOPSY SYSTEM - COMPREHENSIVE NEEDLE TRAY

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by TELEFLEX 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
    143698
  • Event Risk Class
    II
  • Event Initiated Date
    2016-11-18
  • 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
    Teleflex is recalling this product due to a potential incomplete seal of the outer sterile package. because of the compromised packaging the sterility of the inside drape which is used in preparation for bone marrow aspiration with the oncontrol system cannot be guaranteed. if sterility of the drape is compromised there is a potential for infection to occur.

Device

ONCONTROL BIOPSY SYSTEM - COMPREHENSIVE NEEDLE TRAY
  • Model / Serial
    Model Catalog: 9458-VC-006 (Lot serial: > 10 LOT # Contact Mfg); Model Catalog: 9451-VC-006 (Lot serial: > 10 LOT # Contact Mfg); Model Catalog: 9403-VC-006 (Lot serial: > 10 LOT # Contact Mfg); Model Catalog: 9472-VC-006 (Lot serial: 013261); Model Catalog: 9470-VC-006 (Lot serial: 010859); Model Catalog: 9470-VC-006 (Lot serial: 013261); Model Catalog: 9472-VC-006 (Lot serial: 013108); Model Catalog: 9471-VC-006 (Lot serial: 013108); Model Catalog: 9470-VC-006 (Lot serial: 013108); Model Catalog: 9472-VC-006 (Lot serial: 014324); Model Catalog: 9471-VC-006 (Lot serial: 014324); Model Catalog: 9470-VC-006 (Lot serial: 014324); Model Catalog: 9472-VC-006 (Lot serial: 014126); Model Catalog: 9471-VC-006 (Lot serial: 014126); Model Catalog: 9470-VC-006 (Lot serial: 014126); Model Catalog: 9472-VC-006 (Lot serial: 013889); Model Catalog: 9471-VC-006 (Lot serial: 013889); Model Catalog: 9470-VC-006 (Lot serial: 013889); Model Catalog: 9472-VC-006 (Lot serial: 013260); Model Catalog: 9471-VC-006 (Lot serial: 0132
  • Product Description
    Arrow OnControl Bone Marrow Biopsy System Comprehensive Tray;Arrow OnControl System Sterile Procedure Tray;OnControl Biopsy System Ported Needle Tray;Arrow OnControl Bone Marrow Biopsy System Tray;Arrow OnControl Bone Lesion Biopsy System Tray
  • Manufacturer
    TELEFLEX MEDICAL

Manufacturer

TELEFLEX MEDICAL