Z-3016-2011

AirLife Nebulizer Heater, Catalog Code 2M8021 The AirLife Nebulizer Heater is part of the heated nebulizer...

Name: Z-3016-2011 AirLife Nebulizer Heater, Catalog Code 2M8021 The AirLife Nebulizer Heater is part of the heated nebulizer...
Creator: Carefusion 211 Inc
Published: 2011-07-13
License: https://open.fda.gov/license/

Jaeger Medical GmbH / initiated 2011-07-13 / Terminated

FDA source

Carefusion 211 Inc began a recall of AirLife Nebulizer Heater, Catalog Code 2M8021 The AirLife Nebulizer Heater is part of the heated nebulizer system intended to provide warm bland aerosol... on 2011-07-13. The reason FDA records is "The recall was initiated because CareFusion's Investigation has confirmed the Nebulizer Heater can, over time, develop a failure mode that results in an internal electrical short. The short can result in smoke and...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-3016-2011
Status: Terminated
Initiated: 2011-07-13
Posted: 2011-08-12
Terminated: 2012-04-30
Recalling firm: Jaeger Medical GmbH
Product: AirLife Nebulizer Heater, Catalog Code 2M8021 The AirLife Nebulizer Heater is part of the heated nebulizer system intended to provide warm bland aerosol therapy to respiratory patients. The system is used in conjunction with a standard oxygen flowmeter, which by providing pressurized oxygen powers the nebulizer creating ultra-fine particles in the therapeutic aerosol. The heater warms the solution before it reaches the aerosol jet in the nebulizer and heats the dilution air before it is entrained into the aerosol stream. An aluminum heat exchanger on the nebulizer cap transfers the thermal energy to a nebulizer solution bottle warming the solution prior to aerosolizing.
Product code: CAF Nebulizer (Direct Patient Interface)
Reason for recall: The recall was initiated because CareFusion's Investigation has confirmed the Nebulizer Heater can, over time, develop a failure mode that results in an internal electrical short. The short can result in smoke and sparks being emitted from the device. In the presence of oxygen enriched environments and a fuel source, this failure represents a potential risk of flame. CareFusion is voluntarily rec
FDA root cause: Other
Action: Carefusion sent a URGENT PRODUCT RECALL letter dated July 15, 2011, to all affected customers. The letter identified the product, the problem, and the action needed to be taken by the customer. Customers were instructed to examine their inventory for the affected product as indicated on the sample shown in the enclosed Attachment A-1 and remove any affected heaters present in their facility. Confirm the total number of affected units in their possession and enter the quantity and respective serial number on the enclosed Customer Response Card (Attachment A-2). Customers were instructed to contact CareFusion's Technical Support Department at 800-554-8933, (6:30 am to 5:00 pm PDST), to obtain an RMA (returned materials authorization) number for the return of the affected product. Upon receipt of their response, CareFusion will ship to their customers new replacement Nebulizer Heaters in exchange for the affected units. Customers were instructed to acknowledge receipt of this communication by completing the enclosed Customer Response Card and faxing or sending a copy by return mail to the address indicated on the Customer Response Card, (Attachment A-2).
Quantity in commerce: 22,670 units total
Distribution: Nationwide Distribution
Product codes and lots: identified by with serial number logic of TXXXXX or SXXXXX.

Product code CAF

K780456Class IINebulizer HeaterTravenol Laboratories, S.A. / cleared 1978-04-12

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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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)