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Vyaire Medical Recall 93821

Description: AirLife Adult Manual Resuscitator, Variable Volume Oxygen Reservoir Tubing, Adult Mask, REF 2K8017

Vyaire Medical Recall 93821 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1064-2024
Event ID93821
Event DescriptionAirLife Adult Manual Resuscitator, Variable Volume Oxygen Reservoir Tubing, Adult Mask, REF 2K8017
Product TypeDevices
DistributionWorldwide distribution. US nationwide, Brazil, Canada, Switzerland, France, UK, Mexico, Netherlands, Saudi Arabia, Sweden, and South Africa
Quantity1,020,330 units
Recall ReasonRisk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ventilation or no ventilation that may result in hypoventilation or hypoxia, and potentially lead to death. The mold/tooling used to produce the affected component was replaced in 2017.
Device Classification20240306
Device Code InfoUDI/DI Case: 50190752114294, Each: 10190752114296; All manufacturing dates of 2017 and prior, and any products without a manufacturing date.
Center Classification Date20240224
Recall Initiation Date20240110
Recalling FirmVyaire Medical
Initial Notification Letter
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