Events

Recall of Sarns brand Retrograde Cardioplegia Cannulae, auto-inflate, 13 Fr, malleable stylet, ribbed balloon, extended length, 14'' (35 cm) long; catalog number 5584.

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
    29475
  • Event Risk Class
    Class 2
  • Event Number
    Z-1352-04
  • Event Initiated Date
    2004-07-07
  • Event Date Posted
    2004-08-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-10-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34323
  • 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 was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
  • Reason
    The product is labeled as sterile, but sterility is compromised because some of the packages were not sealed.
  • Action
    The firm issued a recall letter for some lots on 7/7/04, instructing customers to examine stocks on hand for open packages and to return product without a package seal. The recall was extended to all lots via a second recall letter dated July 29, 2004.

Device

Sarns brand Retrograde Cardioplegia Cannulae, auto-inflate, 13 Fr, malleable stylet, ribbed ballo...
  • Model / Serial
    All lots.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    United States, Brazil, Canada, Chile, Colombia, El Salvador, Germany, Hong Kong, Malaysia, Mexico, Nicaragua, South Africa, Taiwan, Thailand, United Arab Emirate, Uruguay and Wales.
  • Product Description
    Sarns brand Retrograde Cardioplegia Cannulae, auto-inflate, 13 Fr, malleable stylet, ribbed balloon, extended length, 14'' (35 cm) long; catalog number 5584.
  • Manufacturer
    Terumo Cardiovascular Systems Corp

Manufacturer

Terumo Cardiovascular Systems Corp
  • Manufacturer Address
    Terumo Cardiovascular Systems Corp, 6200 Jackson Rd, Ann Arbor MI 48103-9586
  • Source
    USFDA