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Orise gel pack and procedure kit
Official notice
30 Dec 2022
Last checked
30 Dec 2022
An official Health Canada notice concerns Orise gel pack and procedure kit. Boston Scientific (BSC) initiated a field action in October 2022, communicating that remnant orise gel post-procedure can cause a foreign body reaction, appearing as mass formations and submucosal distortions. Since this time, BSC has become aware of additional events leading to unnecessary medical and surgical intervention. As a result, BSC now believes the occurrence is potentially higher than anticipated, therefore, this product is being removed from the market. Recall start date: December 15, 2022 Published 2022-12-30.
What to do now
Contact the manufacturer if you require additional information.
Recall number
72503
Official notice
2022-12-30
The hazard
The hazard
Boston Scientific (BSC) initiated a field action in October 2022, communicating that remnant orise gel post-procedure can cause a foreign body reaction, appearing as mass formations and submucosal distortions. Since this time, BSC has become aware of additional events leading to unnecessary medical and surgical intervention. As a result, BSC now believes the occurrence is potentially higher than anticipated, therefore, this product is being removed from the market. Recall start date: December 15, 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
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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: Boston Scientific, Orise Gel Pack And Procedure Kit.
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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