Public recall detail

Airflow™, SafeSpot™ and Horizon™ Resuscitators

2024-02-07

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Recall Safety notice
Quick summary

Quick summary: Airflow™, SafeSpot™ and Horizon™ Resuscitators. Date: 2024-02-07.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Airflow™, SafeSpot™ and Horizon™ Resuscitators. Date: 2024-02-07.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandSunmed Holdings, LLC Dba Ventlab, LLC
ProductAirflow™, SafeSpot™ and Horizon™ Resuscitators
IssueMedical devices - Device compatibility
Recall classType II
IdentificationRA-75028

Affected products

ProductAirflow™ Small Child Resuscitator (AF4000 Series)
LotAll lots.
ModelAF4100MBP
Serial numberAll lots.
DescriptionAirflow™ Small Child Resuscitator (AF4000 Series)
ProductSafeSpot™ Infant Resuscitator (SS3200 Series)
LotAll lots.
ModelSS3200MB SS3200MB-2
Serial numberAll lots.
DescriptionSafeSpot™ Infant Resuscitator (SS3200 Series)
ProductAirflow™ Pediatric Resuscitator (AF2000 Series)
LotAll lots.
ModelAF2140MB-PW AF2100MB
Serial numberAll lots.
DescriptionAirflow™ Pediatric Resuscitator (AF2000 Series)
ProductAirflow™ Infant Resuscitator (AF3000 Series)
LotAll lots.
ModelAF3100MB AF3100MBP AF3100MB-M1
Serial numberAll lots.
DescriptionAirflow™ Infant Resuscitator (AF3000 Series)
ProductAirflow™ Small Adult Resuscitator (AF5000 Series)
LotAll lots.
ModelAF5140MBS AF5100MB
Serial numberAll lots.
DescriptionAirflow™ Small Adult Resuscitator (AF5000 Series)
ProductHorizon™ Adult Resuscitator
LotAll lots.
ModelHZI9111
Serial numberAll lots.
DescriptionHorizon™ Adult Resuscitator

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Anaesthesiology
CompaniesSunmed Holdings, LLC Dba Ventlab, LLC 2710 Northridge Drive Nw, Grand Rapids, Michigan, United States, 49544
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-75028
Background{}
CompaniesSunmed Holdings, LLC Dba Ventlab, LLC 2710 Northridge Drive Nw, Grand Rapids, Michigan, United States, 49544
AudiencesHealthcare
Source updated2024-02-07

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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