Adult AirLife dual-limb, dual-heat circuit (Model AH280) with 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.
FDA Recall Z-0346-2018 · Posted 2018-01-24
Recalling FirmVyaire Medical
Recall StatusTerminated
Product CodeBTT
Date Initiated2014-11-29
Date Terminated2021-02-05
Product Quantity16,670 units in total
Reason for Recall
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.
Firm 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 destruction protocol.
~ If you are a healthcare facility or distributor that has further distributed affected product you must further notify your customers of this URGENT RECALL NOTIFICATION.
CUSTOMERS THAT HAVE PURCHASED DIRECT FROM VYAIRE:
~ Complete the Customer Response Form (Appendix 2) and return to [email protected]
~ If you wish to receive credit of your in-stock product affected by this recall or to place an order for the replacement Model/Part Numbers (as referenced per #6. Per the FAQ's) please contact Vyaire Medical's Customer Service Department at 800.323.9088 (Option #1, followed by Option #1) Monday-Friday 8:00 am CST - 5:00 pm CST.
*Please have your original PO number available when calling to expedite the credit process.
CUSTOMERS THAT HAVE PURCHASED THROUGH A DISTRIBUTOR:
~ Please work with your distributor to receive credit of your in-stock product affected by this recall.
For any additional questions and support concerning this voluntary recall, please contact Clinical Risk Coordinator, at 827-757-0109 or [email protected].
Root Cause
Process control
Distribution Pattern
US Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.