Recall Z-1058-2024
Vyaire Medical · initiated January 10, 2024
Class I – dangerous or defective products that could cause serious health problems or death
Product
AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, without Mask, REF 2K8001
Codes / lots: UDI/DI Case: 50190752114096, Each: 10190752114098; All manufacturing dates of 2017 and prior, and any products without a manufacturing date.
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.
FDA-determined 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.
Details
- Recall number
- Z-1058-2024
- Initiated
- January 10, 2024
- Posted by FDA
- February 25, 2024
- Product code
- BTM – Ventilator, Emergency, Manual (Resuscitator)
- Quantity
- 66,078 units
- Distribution
- Worldwide distribution. US nationwide, Brazil, Canada, Switzerland, France, UK, Mexico, Netherlands, Saudi Arabia, Sweden, and South Africa
- Recalling firm
- Vyaire Medical, Mettawa, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1057-2024 Class I | AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, without Mask, REF 2K8000,Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling… | 01/10/2024Open, Classified |
| Z-1059-2024 Class I | AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Expiratory Filter, REF 2K8004FRisk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling… | 01/10/2024Open, Classified |
| Z-1060-2024 Class I | AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Adult Mask, CO2 Detector, REF…Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling… | 01/10/2024Open, Classified |
| Z-1061-2024 Class I | AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF…Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling… | 01/10/2024Open, Classified |
| Z-1062-2024 Class I | AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask…Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling… | 01/10/2024Open, Classified |
| Z-1063-2024 Class I | AirLife Adult Manual Resuscitator, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask, CO2…Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling… | 01/10/2024Open, Classified |
| Z-1064-2024 Class I | AirLife Adult Manual Resuscitator, Variable Volume Oxygen Reservoir Tubing, Adult Mask…Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling… | 01/10/2024Open, Classified |
| Z-1065-2024 Class I | AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF…Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling… | 01/10/2024Open, Classified |