Events

Recall of COBE Spectra

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by CaridianBCT, 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
    53828
  • Event Risk Class
    Class 2
  • Event Number
    Z-1504-2012
  • Event Initiated Date
    2011-10-26
  • Event Date Posted
    2012-05-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108941
  • 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
    blood warmer - Product Code LKN
  • Reason
    Potential for air entry into the fluid pathway of the cobe spectra due to a leak at the return luer connection to an elevated bloodwarmer when directions for use are not followed.
  • Action
    Caridian BCT sent a letter to customers dated June 2011. It was a Field labeling addendum to the COBE Spectra Apheresis System Operator's Manual stating: "When connecting a blood warmer tubing set to the return line, ensure that the tubing connection is tight. Put the luer connection no higher than 20 in (50 cm) above the return access to prevent the possibility of air entering the tubing." This correction was distributed to all consignees and is included with the current version of the owner's manual.

Device

COBE Spectra
  • Model / Serial
    All serial numbers.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Worldwide distribution including USA, Canada, Algeria, Argentina, Australia, Austria, Bahamas, Belgium, Brazil, Chile, China, Colombia, Czech Republic, Denmark, Netherlands, UK, Hong Kong, Hungary, India, Italy, Iran, Ireland, Israel, Jordan, Korea, Kuwait, Lebanon, Libya, Luxembourg, Egypt, Finland, France, Germany, Japan, Malaysia, Mexico, Norway, Oman, Pakistan, Philippines, Poland, Portugal, Romania, Russia, Spain, Saudi Arabia, South Africa, Sweden, Switzerland, Taiwan, Thailand, Ukraine, Uruguay, Vatican, Vietnam, and Greece.
  • Product Description
    Caridian BCT COBE Spectra System Blood Warmer, Catalog number 950000000.
  • Manufacturer
    CaridianBCT, Inc.

Manufacturer

CaridianBCT, Inc.
  • Manufacturer Address
    CaridianBCT, Inc., 10811 W Collins Ave, Lakewood CO 80215-4440
  • Source
    USFDA