Events

Recall of CATH LAB INTERVENT'L SUPER ARROW-FLEX PERCUT SHEATH INTRO SETS - ADULT

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
    75048
  • Event Risk Class
    II
  • Event Initiated Date
    2016-01-21
  • 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 has issued a recall for these products due to potential packaging damage. therefore the sterility of the product cannot be guaranteed. if a non-sterile product is used there is potential for infection to occur. no patient injuries have been reported related to this issue.

Device

CATH LAB INTERVENT'L SUPER ARROW-FLEX PERCUT SHEATH INTRO SETS - ADULT
  • Model / Serial
    Model Catalog: CL-07835 (Lot serial: > 1000 numbers contact mfg); Model Catalog: CL-07735 (Lot serial: > 1000 numbers contact mfg); Model Catalog: CL-07635 (Lot serial: > 1000 numbers contact mfg); Model Catalog: CL-07035 (Lot serial: > 1000 numbers contact mfg)
  • Product Description
    ARROW SUPER ARROW-FLEX PERCUTANEOUS SHEATH INTRODUCER SET
  • Manufacturer
    TELEFLEX MEDICAL CANADA INC.

Manufacturer

TELEFLEX MEDICAL CANADA INC.