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Health Canada Medical devices

Negative Pressure Wound Therapy Sved Device

Issued April 25, 2022
Issue
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
Hazard description
Revised instructions for use
Product
Product name
Negative Pressure Wound Therapy Sved Device
Reference
ID
RA-64113