Airflow™, SafeSpot™ and Horizon™ Resuscitators
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
Airflow™ Small Child Resuscitator (AF4000 Series) |
All lots. |
AF4100MBP |
SafeSpot™ Infant Resuscitator (SS3200 Series) |
All lots. |
SS3200MB |
Airflow™ Pediatric Resuscitator (AF2000 Series) |
All lots. |
AF2140MB-PW |
Airflow™ Infant Resuscitator (AF3000 Series) |
All lots. |
AF3100MB |
Airflow™ Small Adult Resuscitator (AF5000 Series) |
All lots. |
AF5140MBS |
Horizon™ Adult Resuscitator |
All lots. |
HZI9111 |
Issue
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
Additional information
Details
Sunmed Holdings, LLC Dba Ventlab, LLC
2710 Northridge Drive Nw, Grand Rapids, Michigan, United States, 49544
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