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Cobe 2991 disposable sets
Official notice
13 Nov 2024
Last checked
13 Nov 2024
An official Health Canada notice concerns Cobe 2991 disposable sets. 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 Published 2024-11-13.
What to do now
Instructions to be provided by manufacturer on how to mitigate risk and not use affected devices.
Recall number
76493
Official notice
2024-11-13
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
Recall Numbers
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Affected products
Product 1
Product 2
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Terumo Bct, Cobe 2991 Disposable Sets.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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