Z-0346-2018Class I

Adult AirLife dual-limb, dual-heat circuit (Model AH280) with AirLife Humidification Chamber, Model Number...

Name: Z-0346-2018 Adult AirLife dual-limb, dual-heat circuit (Model AH280) with AirLife Humidification Chamber, Model Number...
Creator: Vyaire Medical
Published: 2014-11-29
License: https://open.fda.gov/license/

Jaeger Medical GmbH / initiated 2014-11-29 / Terminated / root cause: manufacturing process

FDA source

Vyaire Medical began a recall of Adult AirLife dual-limb, dual-heat circuit (Model AH280) with AirLife Humidification Chamber, Model Number AH290. The AH290 Humidification Chamber and Heated... on 2014-11-29. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0346-2018
Classification: Class I
Status: Terminated
Initiated: 2014-11-29
Posted: 2018-01-24
Terminated: 2021-02-05
Recalling firm: Jaeger Medical GmbH
Product: 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.
Product code: BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
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.
Root cause tag: manufacturing process
FDA 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 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].
Quantity in commerce: 16,670 units in total
Distribution: US Nationwide Distribution
Product codes and lots: 0001100127 0001116871 0001116872 0001124936 0001129065 0001129066 0001129067 0001129069 0001129070 0001131426 0001131428 0001134350 0001135400 0001136027 0001136028 0001136029 0001145151 0001145152 0001145153 0001157125

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0346-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0343-2018	Class I	Terminated	Voluntary: Firm initiated	2018-01-31	2018-01-24
Z-0344-2018	Class I	Terminated	Voluntary: Firm initiated	2018-01-31	2018-01-24
Z-0345-2018	Class I	Terminated	Voluntary: Firm initiated	2018-01-31	2018-01-24
Z-0346-2018	Class I	Terminated	Voluntary: Firm initiated	2018-01-31	2018-01-24

Product code BTT

K160764Class IIAirLife Autofill Humidification ChamberCarefusion 2200, Inc. / cleared 2016-08-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)