Airflow™, SafeSpot™ and Horizon™ Resuscitators
Last updated
Summary
Product
Airflow™, SafeSpot™ and Horizon™ Resuscitators
Issue
Medical devices - Device compatibility
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
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 SS3200MB-2 |
| Airflow™ Pediatric Resuscitator (AF2000 Series) | All lots. | AF2140MB-PW AF2100MB |
| Airflow™ Infant Resuscitator (AF3000 Series) | All lots. | AF3100MB AF3100MBP AF3100MB-M1 |
| Airflow™ Small Adult Resuscitator (AF5000 Series) | All lots. | AF5140MBS AF5100MB |
| 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
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Anaesthesiology
Companies
Sunmed Holdings, LLC Dba Ventlab, LLC
2710 Northridge Drive Nw, Grand Rapids, Michigan, United States, 49544
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75028
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