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Medical Device Recall: Cobe Spectra Apheresis System Disposable Tubing Sets

Posted Jul 16 2010 4:48am

DATE RECALL INITIATED:

July 12, 2010

PRODUCT / LOT NUMBER /CATALOG NUMBER:

Lot NumberTubing Set NameCatalog
 0S15238
WBC SET, SPECTRA
 70600
 0S15239
FUNCTIONALLY CLOSED WBC SET, SPECTRA
 70620
MANUFACTURER:
CaridianBCT, Inc
Lakewood, Colorado
REASON:
CaridianBCT has received an increased number of reports of leaks at the return luer connection on two (2) lots of COBE Spectra White Blood Cell disposable tubing sets. The leak is observed as a very small fluid leak originating between the male luer on the return line and the attached customer needle OR as an observation of air in the line when blood warmer tubing is attached to the male luer. Customers are asked to discontinue the use of these lots and to contact CaridianBCT to arrange for product return.
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The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.
    
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