Events

Recall of SARNS HIGH FLOW AORTIC ARCH CANNULA

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by RYAN MEDICAL DISTRIBUTORS 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
    44081
  • Event Risk Class
    II
  • Event Initiated Date
    2013-01-14
  • 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
    During an in-house inspection terumo cardiovascular systems (terumo cvs) identified the presence of excess plastic material or flash on a proportion of connectors used for the sarns flexible arterial cannula and the sarns high-flow aortic arch cannula. the flash originated from a molding tool and is located on the exterior of the connector. there is a potential for the flash to detach. terumo cvs is advising users to discontinue use and return all affected cannulae in inventory.

Device

SARNS HIGH FLOW AORTIC ARCH CANNULA
  • Model / Serial
    Model Catalog: 12325 (Lot serial: 0680122); Model Catalog: 13020 (Lot serial: 0677284); Model Catalog: 13020 (Lot serial: 0677287); Model Catalog: 13030 (Lot serial: 0677284); Model Catalog: 12325 (Lot serial: 0680751); Model Catalog: 13030 (Lot serial: 0677287)
  • Product Description
    SARNS HIGH-FLOW AORTIC ARCH CANNULA 6.5 MM (20 FR) OD WITH 3/8" CONNECTOR 11" (28 CM) LONG
  • Manufacturer
    RYAN MEDICAL DISTRIBUTORS INC.

Manufacturer

RYAN MEDICAL DISTRIBUTORS INC.