AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, without Mask, REF 2K8001
This recall is currently active, issued February 25, 2024. It was issued by Vyaire Medical.
- Company
- Vyaire Medical
- Recall Initiated
- January 10, 2024
- Posted
- February 25, 2024
- Recall Number
- Z-1058-2024
- Quantity
- 66,078 units
- Firm Location
- Mettawa, IL
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide distribution. US nationwide, Brazil, Canada, Switzerland, France, UK, Mexico, Netherlands, Saudi Arabia, Sweden, and South Africa
Lot / Code Info
UDI/DI Case: 50190752114096, Each: 10190752114098; All manufacturing dates of 2017 and prior, and any products without a manufacturing date.
Root Cause
Process control
Action Taken
Vyaire issued an URGENT: Customer notification Letter to its consignees on 01/10/2024 via letter delivered by UPS Next Day Air. The notice explained the problem, complaints received, and requested the consignee discard or destroy all affected devices. If the consignee further distributed the product, they were directed to forward a copy of the notice to those parties.