COBE 2991 Disposable Sets
Brand(s)
Summary
Instructions to be provided by manufacturer on how to mitigate risk and not use affected devices.
Affected products
Affected products |
Lot or serial number |
Model or catalogue number |
|---|---|---|
COBE 2991 Blood Processing Set |
More than 10 numbers, contact manufacturer. |
90819 |
Triple Processing Set |
10G15203 |
90901 |
Issue
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
Additional information
Details
| Terumo Bct, Inc. |
| 10811 W. Collins Avenue, Lakewood, Colorado, United States, 80215 |
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