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Xvivo organ chamber
Official notice
25 Apr 2022
Last checked
25 Apr 2022
An official Health Canada notice concerns Xvivo organ chamber. It has come to Xvivo knowledge that the sterile barrier (welded polybag) show defects in the weld for a number of batches of the Xvivo Organ Chamber. Defect was categorized as unsealed sections of the weld (compromised sterile barrier). To reinforce the instructions for use and emphasize the user to check the package in detail as described in the instructions for use, it was decided to issue a recall common to customers who have received devices for the batches affected. Recall start date: Apr 11, 2022 Published 2022-04-25.
What to do now
Contact the manufacturer if you require additional information.
Recall number
64106
Official notice
2022-04-25
The hazard
The hazard
It has come to Xvivo knowledge that the sterile barrier (welded polybag) show defects in the weld for a number of batches of the Xvivo Organ Chamber. Defect was categorized as unsealed sections of the weld (compromised sterile barrier). To reinforce the instructions for use and emphasize the user to check the package in detail as described in the instructions for use, it was decided to issue a recall common to customers who have received devices for the batches affected. Recall start date: Apr 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.
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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: Vivo, Xvivo Organ Chamber.
Source & status
Source & status
Source
Tier
Category
Classification
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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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