SoKINOX NO Delivery and Monitoring System (2021-01-25)

Starting date:

January 25, 2021

Posting date:

February 5, 2021

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-74933

Last updated:
2021-02-05

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  Reason
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  Affected products

Affected Products 

SoKINOX NO Delivery and Monitoring System

Reason

The manufacturer has received a small number of reports regarding leakage due to malfunction of the pilot valve in the backup system. The leakage could in worst case over time drain the connected NO gas cylinders while the system is not in use if the cylinders are left open during that time.

Affected products