COBE 2991 Disposable Sets
Brand(s)
Last updated
Summary
Product
COBE 2991 Disposable Sets
Issue
Medical devices - Performance
What to do
Instructions to be provided by manufacturer on how to mitigate risk and not use affected devices.
Audience
Healthcare
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 07G15207 02G15222 | 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
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Haematology
Companies
| Terumo Bct, Inc. |
| 10811 W. Collins Avenue, Lakewood, Colorado, United States, 80215 |
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-76493
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