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

FDA device recall Z-3016-2011 · posted 2011-08-12 · Terminated

Recall details

Recalling firm

Carefusion 211 Inc

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

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).

Root cause

Other

Status

Terminated

Product code

CAF

Quantity affected

22,670 units total

Distribution

Nationwide Distribution

Date initiated

2011-07-13

Date posted

2011-08-12

Date terminated

2012-04-30

Location

Yorba Linda, CA

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