FDA Device Recall Z-1059-2024

Vyaire Medical · Mettawa, IL

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death. Distribution is nationwide and the recall remains in progress.

Device

AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Expiratory Filter, REF 2K8004F

Lot / serial / GTIN: UDI/DI Case: 50190752114133, Each: 10190752114135; All manufacturing dates of 2017 and prior, and any products without a manufacturing date.

Quantity: 8,220 units

Reason for recall

Risk 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.

Recall record

Recall number: Z-1059-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Worldwide distribution. US nationwide, Brazil, Canada, Switzerland, France, UK, Mexico, Netherlands, Saudi Arabia, Sweden, and South Africa
Recall initiated: 2024-01-10
Classified by FDA Center: 2024-02-24
FDA published: 2024-03-06
Recalling firm: Vyaire Medical
Firm location: Mettawa, IL

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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