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Sureform 45 60
Official notice
4 Apr 2022
Last checked
4 Apr 2022
An official Health Canada notice concerns Sureform 45 60. A review of complaints on Sureform PNs 480445, 480545, 480460 was done to determine rate of harm due to tissue pushout events. This action was completed as part of an internal capa. Sureform complaint data from October 1, 2019 through September 30, 2021 was reviewed. Overall rate of harm associated with bleeding (tissue pushout events) of critical severity exceeds the predicted likelihood of harm as documented. Recall start date: Mar 17, 2022 Published 2022-04-04.
What to do now
Contact the manufacturer if you require additional information.
Recall number
64037
Official notice
2022-04-04
The hazard
The hazard
A review of complaints on Sureform PNs 480445, 480545, 480460 was done to determine rate of harm due to tissue pushout events. This action was completed as part of an internal capa. Sureform complaint data from October 1, 2019 through September 30, 2021 was reviewed. Overall rate of harm associated with bleeding (tissue pushout events) of critical severity exceeds the predicted likelihood of harm as documented. Recall start date: Mar 17, 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
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: Intuitive Surgical, Sureform 45 60.
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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