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U.S. Department of Health and Human Services

Medical Devices

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CareFusion 2200 Inc., Care Fusion Airlife Infant Breathing Circuit

Recall Class: Class I

Date Recall Initiated: May 29, 2012

Products: Care Fusion Airlife Infant Breathing Circuit

Lot Numbers:

Includes all lot numbers less than lot #0000414257 or beginning with the letter “Y” for all product codes manufactured prior to February 3, 2012 as listed below:

10127-4H1, 10331N-4S2, 10351-4H2, 10387-4S2, 10555-4S2, 10706-4S2, 10790-4S2, 10814-4S2, 10849-4S2, 1175-4H2, 1208-4H1, 1553-4H1, 1815-409, 1998-4H1, 2119-4S2G, 2120-4S2G, 4319-4H2, 4326-4H2, 4652-501, 4677-4H2, 4875-4H2, 5665-4H2, 5682-409, 5732-4H1, 5868-4H2, 6002-4H2, 6040-501, 6074-4H1, 6198-4H2, 6274-H12, 6301-H12, 6313-501, 6459-4H2; 6485-4H2, 6588-4H2, 6942-4H2, 7100-4S2, 7147-4S2, 7156-4S2, 7184-4S2, 7206-4S2, 7213-4S2, 7354-4S2, 7395-4S2, 7407-4S2, 7441-4S2, 7483-4S2, 7526-4S2, 7575-4S2, 7582-4S2, 7588-4S2, 9053-4S2, 9054-4S2, 9055-4S2, 9056-4S2, 9058-4S2, RC41-12027, RC41-18039, RC41-18052, RC41-18060, RC51-12074, RC51-18004, RT4851-00, RT4851-12, RT4851-18, 0260-503, 0778-503, 10392-503,10416-503, 10448-507, 10734-503, 10852-503, 1209-503, 1553-4H1, 1853-503, 5599-503, 5643-503, 5898-503, 5925-504, 6189-503, 6603-504, 6800-503, 9052-4S2 and RC41-00097

Manufacturing dates: June 30, 2010 through February 3, 2012

Distribution dates: July 1, 2010 through May 7, 2012

Use: The respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient.

Recalling Firm:

CareFusion 2200 Inc.
3750 Torrey View Ct.
San Diego, California 92130-2622

Reason for Recall:

The Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ventilation system. This leak could lead to a decrease in the tidal volume delivered to the ventilated patient. These products may cause serious adverse health consequences, including death.

Public Contact:

Consumers may contact Mr. David Wehrheim at 1-847-473-7495 or by e-mail at David.Wehrheim@CareFusion.com

FDA District: Chicago District Office

FDA Comments:

On May 29, 2012, the firm sent Urgent Recall Notices to customers and its distributors, informing them of the receipt of complaints reporting cracks developing in the Y adapter during use of the breathing circuits, which could cause a safety risk to the ventilated patient. The distributors were requested to immediately destroy any affected product in-stock at their facilities and to cease distributing these products. They were also requested to forward the recall notice to any customers to whom these products were sold, notifying them of the potential risk. The customers were instructed to return any unused product to the distributor.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.

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