Company: Terumo BCT, Inc.
Date of Enforcement Report:10/1/2014
Class lII:
PRODUCT
TerumoBCT, Lakewood, CO 80215 USA. Catalog No: 6100 Spectra Optia Apheresis System Recall Number B-0995-14
REASON
Spectra Optia Apheresis Systems with version 11 software, associated with unexpected behavior regarding rinseback, were distributed.
RECALLING FIRM/MANUFACTURER
Terumo BCT, Inc., Lakewood, CO on 8/27/2014 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
393
DISTRIBUTION
Nationwide and Internationally
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