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Airflow™, safespot™ and horizon™ resuscitators
Official notice
7 Feb 2024
Last checked
7 Feb 2024
An official Health Canada notice concerns Airflow™, safespot™ and horizon™ resuscitators. Sunmed Holdings LLC (also trading as Ventlab LLC) is updating its IFU for the manual resuscitators to include a warning statement. A safety bulletin was issued relative to the use of accessories (e.g., peep valve) on the exhalation port of the manual resuscitator which may increase the backward leak due to increased expiratory resistance and that monitoring of end tidal carbon dioxide is recommended in critically ill patients. Recall start date: October 11, 2023 Published 2024-02-07.
What to do now
Contact the manufacturer if you require additional information.
Recall number
75028
Official notice
2024-02-07
The hazard
The hazard
Sunmed Holdings LLC (also trading as Ventlab LLC) is updating its IFU for the manual resuscitators to include a warning statement. A safety bulletin was issued relative to the use of accessories (e.g., peep valve) on the exhalation port of the manual resuscitator which may increase the backward leak due to increased expiratory resistance and that monitoring of end tidal carbon dioxide is recommended in critically ill patients. Recall start date: October 11, 2023
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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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
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Brand: Sunmed Dba Ventlab, Airflow™ Safespot™ And Horizon™ Resuscitators.
Source & status
Source & status
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Recall details
Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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