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Coloplast catheters
Official notice
30 Dec 2024
Last checked
30 Dec 2024
An official Health Canada notice concerns Coloplast catheters. This recall is due to breach in sterility barrier (packaging pouch). The products involved with a sterilization issue was tested to evaluate impact to package integrity (blue-dye penetration test). Pouch integrity failures were observed due to holes in the pouch. This defect is not easily visible by the product's users. Recall start date: December 2, 2024 Published 2024-12-30.
What to do now
Contact the manufacturer if you require additional information.
Recall number
76769
Official notice
2024-12-30
The hazard
The hazard
This recall is due to breach in sterility barrier (packaging pouch). The products involved with a sterilization issue was tested to evaluate impact to package integrity (blue-dye penetration test). Pouch integrity failures were observed due to holes in the pouch. This defect is not easily visible by the product's users. Recall start date: December 2, 2024
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: Coloplast A S, Coloplast Catheters.
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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