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Amplatzer steerable delivery sheath
Official notice
19 Nov 2021
Last checked
19 Nov 2021
An official Health Canada notice concerns Amplatzer steerable delivery sheath. The Hemostasis valve in the closed position is not fully sealed and additional steps are required to prevent air ingress. Abbott is providing instructions (including update to the product instructions for use [IFU] and additional product-related customer training) to reduce the potential for air ingress. Recall start date: 2021-11-09 Published 2021-11-19.
What to do now
Contact the manufacturer if you require additional information
Recall number
63641
Official notice
2021-11-19
The hazard
The hazard
The Hemostasis valve in the closed position is not fully sealed and additional steps are required to prevent air ingress. Abbott is providing instructions (including update to the product instructions for use [IFU] and additional product-related customer training) to reduce the potential for air ingress. Recall start date: 2021-11-09
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
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 Medical, Amplatzer Steerable Delivery Sheath.
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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