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Indeflator device
Official notice
28 Mar 2022
Last checked
28 Mar 2022
An official Health Canada notice concerns Indeflator device. Devices from these lots may exhibit leaks and/or a loose connection at the rotating luer assembly or stopcock connection, which could lead to air ingress under vacuum. Analysis indicates an estimated rate of occurrence of air ingress associated with the device is 0.4%. While no long-term adverse patient effects have been associated with this issue, potential risks include air embolism, thrombosis and foreign body in patient. Recall start date: Mar 11, 2022 Published 2022-03-28.
What to do now
Contact the manufacturer if you require additional information.
Recall number
64029
Official notice
2022-03-28
The hazard
The hazard
Devices from these lots may exhibit leaks and/or a loose connection at the rotating luer assembly or stopcock connection, which could lead to air ingress under vacuum. Analysis indicates an estimated rate of occurrence of air ingress associated with the device is 0.4%. While no long-term adverse patient effects have been associated with this issue, potential risks include air embolism, thrombosis and foreign body in patient. Recall start date: Mar 11, 2022
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
Product 3
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: Abbott Vascular, Indeflator Device.
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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