Events

Recall of Device Recall Sarns Centrifugal Pump with XCoating

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Terumo Cardiovascular 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
    56322
  • Event Risk Class
    Class 2
  • Event Number
    Z-2606-2010
  • Event Initiated Date
    2010-03-15
  • Event Date Posted
    2010-09-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-11-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93229
  • 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
    Centrifugal Pump (Non-Roller Type) - Product Code KFM
  • Reason
    Medical device component may malfunction and require user intervention during surgical bypass procedures.
  • Action
    The recalling firm notified end users, perfusion groups, and distributors by phone, fax, email and mail on 03/15/10 to advise of the required recall actions with instructions for labeling and returning the involved product from the customer level. The firm expanded their recall to include additional lots on 05/17/10. If you have any questions, please contact Customer Service at 800-521-2818.

Device

Device Recall Sarns Centrifugal Pump with XCoating
  • Model / Serial
    Pump manufacturing lots:  MA04 MA11 MA18 MA25 MC01 MC08 MC15 MC22 MD01 LM12 LM19 LN30 LN23 LP21 LM05 MD22 LP14A LP14 LP14AR MA04R LF04A LM26A LN02A MD29 ME05 MA11R MD15 LE13R LF04R LF11R LF18R LM26T LN02T LN09T LN16T LN23T LN30T LP07T LP14T LP21T MA04T MA11T MA11TA MA18A MA18R MA18T MA18TR MA25R MA25T MA25TA MC01T MC08T MC15T MC22T MD08 MD08T MD22T ME12 ME12T ME19 ME19T
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was sold to medical device distributors and to direct accounts nationwide and to a subsidiary in Japan.
  • Product Description
    Sarns Centrifugal Pump with X-Coating, packaged within custom ordered Cardiovascular Procedure Kits, P/N 3ZZ164275X, 3ZZ164275, CEOT028, CEOT032; and as single sterile units with product codes CV-164275, 164275 and 164275X. || CV-164275 is an item number for product that is sold to foreign affiliate. || Usage: The Sarns Centrifugal Pump (with X-Coating) is indicated as an extracorporeal blood pump for use in cardiopulmonary bypass procedures.
  • Manufacturer
    Terumo Cardiovascular Corporation

Manufacturer

Terumo Cardiovascular Corporation
  • Manufacturer Address
    Terumo Cardiovascular Corporation, 125 Blue Ball Road, Elkton MD 21921-5315
  • Manufacturer Parent Company (2017)
    Terumo Corp.
  • Source
    USFDA