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Becker and exacta external drainage and monitoring systems

Official notice

14 Nov 2024

Last checked

14 Nov 2024

Medium riskHealth Canada
Watch Medtronic

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

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

Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.

Recall Numbers

76501

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Affected products

Product 1

Affected products - Exacta With Edm Ventricular Catheter Kit (Barium), Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 27581

Product 2

Affected products - Becker External Drainage And Monitoring System, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 46128

Product 3

Affected products - Exacta Drainage System, 100ml, With Luer Lock, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 46705

Product 4

Affected products - Exacta External Drainage And Monitoring System, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 46700

Risk / 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

Where it was sold

The source does not list specific retailers. See the official notice for where affected vehicles were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

Medtronic, Becker And Exacta External Drainage And Monitoring

Manufacturer

Not provided

Phone

Not provided

Brand: Medtronic, Becker And Exacta External Drainage And Monitoring.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

76501

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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