Official recall record
Airflow™, SafeSpot™ and Horizon™ Resuscitators
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2024-02-07
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
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
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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