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Negative pressure wound therapy sved device

Official notice

25 Apr 2022

Last checked

25 Apr 2022

Medium riskHealth Canada

An official Health Canada notice concerns Negative pressure wound therapy sved device. Cardinal Health is initiating an urgent medical device correction to update the clinician and patient user manuals for the Negative Pressure Wound Therapy Sved Device to add pertinent information related to periodic preventative maintenance for this device. The current three year service life stated in the clinician and patient user manuals has been augmented to include a requirement to service the units every 3 years or once the unit has reached 75 days of runtime, whichever comes first. Recall start date: Apr 19, 2022 Published 2022-04-25.

What to do now

Contact the manufacturer if you require additional information.

Recall number

64113

Official notice

2022-04-25

The hazard

Cardinal Health is initiating an urgent medical device correction to update the clinician and patient user manuals for the Negative Pressure Wound Therapy Sved Device to add pertinent information related to periodic preventative maintenance for this device. The current three year service life stated in the clinician and patient user manuals has been augmented to include a requirement to service the units every 3 years or once the unit has reached 75 days of runtime, whichever comes first. Recall start date: Apr 19, 2022

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

64113

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Affected products

Product 1

Affected Products - Negative Pressure Wound Therapy Sved Device, Lot or Serial Number - All lots., Model or catalog number - 6701132BL, 6701132BL-DE, 6701132, 6701132BL-A

Risk / hazard

Cardinal Health is initiating an urgent medical device correction to update the clinician and patient user manuals for the Negative Pressure Wound Therapy Sved Device to add pertinent information related to periodic preventative maintenance for this device. The current three year service life stated in the clinician and patient user manuals has been augmented to include a requirement to service the units every 3 years or once the unit has reached 75 days of runtime, whichever comes first. Recall start date: Apr 19, 2022

Where it was sold

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

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Cardinal Health, Negative Pressure Wound Therapy Sved Device.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

64113

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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