Class 2 Device Recall AirLife Nebulizer Heater

• Date Initiated by Firm: July 13, 2011
• Date Posted: August 12, 2011
• Recall Status: Terminated on April 30, 2012
• Recall Number: Z-3016-2011
• Recall Event ID: 59376
• 510(K)Number: K780456
• Product Classification: nebulizer (direct patient interface) - Product Code CAF
• 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.
• Code Information: identified by with serial number logic of TXXXXX or SXXXXX.
• Recalling Firm/ Manufacturer: Carefusion 211 Inc; 22745 Savi Ranch Pkwy; Yorba Linda CA 92887-4668
• For Additional Information Contact: 714-919-3342
• Manufacturer 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 Determined 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = CAF and Original Applicant = TRAVENOL LABORATORIES, S.A.