BEUDAMED
    FDA Recall Terminated

    Caridian BCT COBE Spectra System Blood Warmer, Catalog number 950000000.

    Recall: Z-1504-2012 · Initiated October 26, 2011

    Recall

    Recall Number
    Z-1504-2012
    Event Number
    53828
    Firm
    CaridianBCT, Inc.
    FEI Number
    1000117351
    Product Code
    LKN
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 26, 2011
    Posted
    May 9, 2012
    Terminated
    May 11, 2012
    Address
    10811 W Collins Ave, Lakewood, CO, 80215-4440

    Description

    Caridian BCT COBE Spectra System Blood Warmer, Catalog number 950000000.

    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.

    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.

    Quantity

    2459 machines