Events

Recall of Sarns brand Retrograde Cardioplegia Cannula, 17 Fr, steerable stylet, ribbed balloon, manual-inflate. Catalog # 4428

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Terumo Cardiovascular Systems Corp.

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
    27041
  • Event Risk Class
    Class 2
  • Event Number
    Z-1190-03
  • Event Initiated Date
    2003-08-08
  • Event Date Posted
    2003-08-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-03-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29049
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    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 data.
  • Extra notes in the data
    unknown device name - Product Code 74DWF
  • Reason
    Product is labeled as sterile, but inadequate package seal results in lack of assurance of sterility.
  • Action
    Urgent device recall letters were sent to customers on August 8, 2003. Distributors were advised to notify their customers of this recall. Product is to be returned to Terumo.

Device

Sarns brand Retrograde Cardioplegia Cannula, 17 Fr, steerable stylet, ribbed balloon, manual-infl...
  • Model / Serial
    Lots 1200590 and 1200600.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    United States, Canada, Chile, China, Germany and Japan.
  • Product Description
    Sarns brand Retrograde Cardioplegia Cannula, 17 Fr, steerable stylet, ribbed balloon, manual-inflate. Catalog # 4428
  • Manufacturer
    Terumo Cardiovascular Systems Corp

Manufacturer

Terumo Cardiovascular Systems Corp
  • Manufacturer Address
    Terumo Cardiovascular Systems Corp, 6200 Jackson Rd., Ann Arbor MI 48103
  • Source
    USFDA