Events

Recall of NRG TRANSSEPTAL NEEDLE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BAYLIS MEDICAL COMPANY 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
    53582
  • Event Risk Class
    II
  • Event Initiated Date
    2016-10-12
  • 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
    Through baylis medical company's internal process for non-conforming materials and deviations a possibility for an integrity defect to the tyvek pouch of the nrg transseptal needle was identified.

Device

NRG TRANSSEPTAL NEEDLE
  • Model / Serial
    Model Catalog: NRG-HF-71-C0 (Lot serial: >10. Contact mfr.); Model Catalog: NRG-E-HF-98-C0 (Lot serial: >10. Contact mfr.); Model Catalog: NRG-71-C1 (Lot serial: >10. Contact mfr.); Model Catalog: NRG-E-HF-71-C1 (Lot serial: >10. Contact mfr.); Model Catalog: NRG-E-HF-71-C0 (Lot serial: >10. Contact mfr.); Model Catalog: NRG-HF-98-C1 (Lot serial: >10. Contact mfr.); Model Catalog: NTK-710-8545 (Lot serial: >10. Contact mfr.); Model Catalog: NRG-HF-71-C1 (Lot serial: >10. Contact mfr.)
  • Product Description
    NRG TRANSSEPTAL NEEDLE
  • Manufacturer
    BAYLIS MEDICAL COMPANY INC.

Manufacturer

BAYLIS MEDICAL COMPANY INC.