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Codman bactiseal evd catheter set
Official notice
29 May 2024
Last checked
29 May 2024
An official Health Canada notice concerns Codman bactiseal evd catheter set. The decision to conduct a voluntary removal of the product was based on the following: through an internal investigation, it was identified that there is a defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the sealing. There is no issue with the inner sterile packaging (tray). However, even if the inner packaging (tray) is sealed correctly, the defect in the outer sterile packaging (pouch) could lead to cross contamination during handling. Recall start date: May 16, 2024 Published 2024-05-29.
What to do now
Contact manufacturer if you require additional information.
Recall number
75577
Official notice
2024-05-29
The hazard
The hazard
The decision to conduct a voluntary removal of the product was based on the following: through an internal investigation, it was identified that there is a defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the sealing. There is no issue with the inner sterile packaging (tray). However, even if the inner packaging (tray) is sealed correctly, the defect in the outer sterile packaging (pouch) could lead to cross contamination during handling. Recall start date: May 16, 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
Manufacturer
Phone
Brand: Integra Lifesciences Production, Codman Bactiseal Evd Catheter Set.
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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