Recall Z-3016-2011
Carefusion 211 Inc · initiated July 13, 2011
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.
Codes / lots: identified by with serial number logic of TXXXXX or SXXXXX.
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 taken
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).
Details
- Recall number
- Z-3016-2011
- Initiated
- July 13, 2011
- Posted by FDA
- August 12, 2011
- Terminated
- April 30, 2012
- Product code
- CAF – Nebulizer (Direct Patient Interface)
- Quantity
- 22,670 units total
- Distribution
- Nationwide Distribution
- Recalling firm
- Carefusion 211 Inc, Yorba Linda, CA