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Stradis implant packs
Official notice
21 Dec 2022
Last checked
21 Dec 2022
An official Health Canada notice concerns Stradis implant packs. Following an internal product review, Stradis identified certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. Use of the kits that do not maintain sterility as a result of the incomplete seal of the outer bag may result in patient risk of infection. Recall start date: November 2, 2022 Published 2022-12-21.
What to do now
Contact the manufacturer if you require additional information.
Recall number
72395
Official notice
2022-12-21
The hazard
The hazard
Following an internal product review, Stradis identified certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. Use of the kits that do not maintain sterility as a result of the incomplete seal of the outer bag may result in patient risk of infection. Recall start date: November 2, 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
Product 4
Product 5
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: Stradis Healthcare, Stradis Implant Packs.
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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