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Becker and exacta external drainage and monitoring systems
Official notice
14 Nov 2024
An official Health Canada notice concerns Becker and exacta external drainage and monitoring systems. Medtronic has received customer complaints reporting cracks and/or leaks on the stopcock of Becker and Exacta EDMS devices. On these devices, the stopcocks may be in three different locations in the EDMS, depending on the specific system configuration. Cracks or leaks of the stopcock can compromise line integrity and, as a result, present a potential for infection. Three adverse events associated with patient infection have been reported. Recall start date: November 1, 2024 Published 2024-11-14.
What to do now
Contact the manufacturer if you require additional information.
Recall number
76501
Official notice
2024-11-14
The hazard
The hazard
Medtronic has received customer complaints reporting cracks and/or leaks on the stopcock of Becker and Exacta EDMS devices. On these devices, the stopcocks may be in three different locations in the EDMS, depending on the specific system configuration. Cracks or leaks of the stopcock can compromise line integrity and, as a result, present a potential for infection. Three adverse events associated with patient infection have been reported. Recall start date: November 1, 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.
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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
Manufacturer
Phone
Brand: Medtronic, Becker And Exacta External Drainage And Monitoring.
Source & status
Source & status
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Tier
Category
Classification
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Recall details
Recall details
Recall number
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Source tier
Documents, notices & source
See the official notice and source documents for full details.
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