Events

Recall of Device Recall Sarns

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

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
    61731
  • Event Risk Class
    Class 2
  • Event Number
    Z-1890-2012
  • Event Initiated Date
    2012-05-09
  • Event Date Posted
    2012-06-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-04-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108828
  • 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
    During production of the sarns antegrade cardioplegia cannula, terumo cardiovascular systems (terumo cvs) identified the presence of a foreign substance on the inner surface of some cannulae tips. terumo cvs' preliminary investigation found that the substance can be dislodged from the cannula surface. the substance was likely deposited during the molding process, but the exact composition of the.
  • Action
    Terumo sent an Urgent Medical Device Recall letter dated May 9, 2012 to All US first consignees will receive a removal notification letter via Federal Express. The letter identified the affected products, reason for correction and actions to be taken. Customers were instructed to discontinue use of affected products and return for replacement. The letter advised customers to assure that all users are aware of this notice and to fill out and return the attached Response Form. For questions call Terumo CVS Customer Service at 1-800-521-2818 or by fax at 1-800-292-6551.

Device

Device Recall Sarns
  • Model / Serial
    Catalog number: 80002-03 and lot number: MH12, MK30, MP06, NE18, NM31, and NN28.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) including the states of: AL, AR , AZ , CA, CT , FL, IA , IL, IN , KS , LA , MI , NM, MO , NC, NE , NJ , NV, NY , OH, OK , PA, RI , SC , TN, TX, WA , WI, WV and the countries of: BELGIUM, BRAZIL, Byelorussian SSR, CAMBODIA , Dominican Republic, Honduras, Japan, Malaysia, Mexico, Nicaragua, Saudi Arabia, Singapore, South Africa, Thailand, Trinidad and Tobago, UNITED ARAB EMIRATES (UAE), and Vietnam.
  • Product Description
    CPB CATHETER KIT- DR OWEN || Product Usage: || The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

Terumo Cardiovascular Systems Corporation
  • Manufacturer Address
    Terumo Cardiovascular Systems Corporation, 6200 Jackson Road, Ann Arbor MI 48103-9586
  • Manufacturer Parent Company (2017)
    Terumo Corp.
  • Source
    USFDA