Recall Z-0343-2018 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Vyaire Medical
Infant AirLife single-limb, continuous-flow circuit (Model AH132) containing AirLife Humidification Chamber, Model Number AH290. The AH290 Humidification Chamber and Heated Breathing Circuit Kit(s) operate as part of a system for delivering health and humidified respirator gasses to patients requiring invasive and non-invasive ventilation.
| Date | Jan 24, 2018 (initiated Nov 29, 2014) |
| Status | Terminated |
| Reason | Manufacturing error in humidification chamber may cause an overfill/overflow condition of the chamber. The may case a water back-up into the patient circuit resulting in an excessive amount of water entering the airway/lungs of the ventilated patient. |
| Root cause | Process control |
| Action | The firm, Vyaire Medical, sent an "URGENT RECALL NOTIFICATION" letter dated November 29th, 2017 to its customers. The recall letter described the product, problem and actions to be taken. The customers were instructed to do the following: "ALL CUSTOMERS: ~ Inspect current inventory on-hand. A 100% physical inventory should immediately be performed to identify and remove affected lots of the AirLife Humidification Chamber(s) and Heated Breathing Circuit Kit(s) due to the identified potential patient safety risk. ~ Destroy all affected product(s) in-stock in accordance with your facility's dest |
| Quantity | 16,670 units in total |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160764 | AirLife Autofill Humidification Chamber Carefusion 2200, Inc., Aug 25, 2016 |