Three (3) separate failure modes have been identified that may lead to procedural interruptions, leaks, and subsequent loss of product during use of select COBE 2991 disposable sets. These failure modes include: 1) an improperly bonded spike receptor on the processing bag, 2) a twisted stem tube due to a seized ceramic bearing, and 3) a small hole (a.k.a. pinhole) on the stem tube below the rotating seal. Recall start date: October 21, 2024
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