Recall Z-1060-2024— Vyaire Medical
Class I · Ongoing
Class I FDA medical device recall by Vyaire Medical, initiated 2024-01-10. FDA's recall record names no specific 510(k) clearance for this event. Product: AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Adult Mask, CO2 Detector, REF 2K8004C2. Reason: 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..
- Recalling firm
- Vyaire Medical
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2024-01-10
- Firm location
- Mettawa, IL, United States
Product description
AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Adult Mask, CO2 Detector, REF 2K8004C2
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.