Events

Recall of PERCUTANEOUS SHEATH INTRODUCER PROCEDURAL KITS WITH SILK SUTURES

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
    49894
  • Event Risk Class
    II
  • Event Initiated Date
    2014-04-30
  • 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
    Arrow is recalling the products referenced above due to dilator tip damage noted during internal inspection of the percutaneous sheath introducer kits. dilator tip damage has the potential to result in vessel damage. there are no reported related illnesses or injuries from the related device.

Device

PERCUTANEOUS SHEATH INTRODUCER PROCEDURAL KITS WITH SILK SUTURES
  • Model / Serial
    Model Catalog: AK-09903-J (Lot serial: 23F13G0400); Model Catalog: SI-09903-E (Lot serial: RF3064915); Model Catalog: SI-09903-E (Lot serial: RF3064710)
  • Product Description
    Percutaneous Sheath Introducer Kits with Silk Sutures
  • Manufacturer
    TELEFLEX MEDICAL CANADA INC.

Manufacturer

TELEFLEX MEDICAL CANADA INC.