Events

Recall of ARTERIAL ACCESS PRODUCTS

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
    48074
  • Event Risk Class
    II
  • Event Initiated Date
    2013-10-18
  • 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
    Arrow is recalling the products referenced in the attachment as there is a risk that the introducer needles packaged within the kits can be partially or fully occluded. if an occluded needle is used on a patient there is risk of delay in treatment and/or adverse event requiring medical intervention.

Device

ARTERIAL ACCESS PRODUCTS
  • Model / Serial
    Model Catalog: AA-15511-3 (Lot serial: > 100 numbers contact mfg); Model Catalog: AA-15611-S (Lot serial: > 100 numbers contact mfg); Model Catalog: AA-15611-3 (Lot serial: > 100 numbers contact mfg); Model Catalog: AA-15511-S (Lot serial: > 100 numbers contact mfg); Model Catalog: AA-10407-1 (Lot serial: > 100 numbers contact mfg); Model Catalog: AA-10611-1 (Lot serial: > 100 numbers contact mfg); Model Catalog: AA-10607-1 (Lot serial: > 100 numbers contact mfg); Model Catalog: AA-10511-1 (Lot serial: > 100 numbers contact mfg); Model Catalog: AA-10507-1 (Lot serial: > 100 numbers contact mfg); Model Catalog: AA-10624-1 (Lot serial: > 100 numbers contact mfg)
  • Product Description
    TransRadial Artery Access Kits
  • Manufacturer
    TELEFLEX MEDICAL CANADA INC.

Manufacturer

TELEFLEX MEDICAL CANADA INC.