Events

Recall of CENTRAL VENOUS CATHETERIZATION KIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by TELEFLEX MEDICAL 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
    16155
  • Event Risk Class
    II
  • Event Initiated Date
    2010-11-01
  • 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
    Some of the outer trays used in the packaging of the products were found to have cracks. therefore the packaging may have been compromised and sterility of the product cannot be guaranted.

Device

CENTRAL VENOUS CATHETERIZATION KIT
  • Model / Serial
    Model Catalog: AK-04650-E (Lot serial: >10 lots Contact manufacturer); Model Catalog: AK-04660 (Lot serial: >10 lots Contact manufacturer); Model Catalog: AK-03000 (Lot serial: >10 Lots Contact manufacturer); Model Catalog: NH-05501 (Lot serial: RL9029591); Model Catalog: NH-05501 (Lot serial: RL9019412); Model Catalog: NH-05501 (Lot serial: RL8118743); Model Catalog: NH-05501 (Lot serial: RF9057542); Model Catalog: NH-05501 (Lot serial: RF9044688); Model Catalog: AK-04050 (Lot serial: >10 lots Contact manufacturer); Model Catalog: NS-04100 (Lot serial: >10 lots Contact manufacturer); Model Catalog: AK-04150-E (Lot serial: >10 lots Contact manufacturer); Model Catalog: ASK-03000-CHUQ (Lot serial: >10 lots Contact manufacturer); Model Catalog: ASK-03000-CHUQ1 (Lot serial: >10 lots Contact manufacturer)
  • Product Description
    CENTRAL VENOUS CATHERIZATION KIT
  • Manufacturer
    TELEFLEX MEDICAL CANADA INC.

Manufacturer

TELEFLEX MEDICAL CANADA INC.