FDA ISSUES RECALL OF CERTAIN INFANT BREATHING CIRCUITS

CareFusion Airlife Infant Breathing Circuit: Class I Recall - Potential for Leak in Closed Ventilation System

AUDIENCE: Anesthesiology, Risk Manager

ISSUE: FDA notified healthcare professionals of the Class 1 recall of the Airlife infant breathing circuit due to the risk that 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. The recalled products were distributed from July 1, 2010 through May 7, 2012.

See the Recall Notice for a listing of affected lot numbers.

BACKGROUND: Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient.

RECOMMENDATION: On May 29, 2012, the firm sent an Urgent Recall Notice to customers and distributors. 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. CareFusion is requesting that customers destroy all affected product or return any unused product to the distributor.

Read the MedWatch safety alert, including a link to the FDA Recall Notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm310871.htm

POSSIBLE LISTERIA CONTAMINATION CAUSES RECALL OF DAIRY PRODUCTS IN MASSACHUSETTS

The following excerpt is from the FDA website:

"December 29, 2011 - The MA Department of Public Health (MDPH) is issuing a warning to consumers to avoid consumption of certain cheese and milk products because the products may be contaminated with Listeria monocytogenes (L. monocytogenes). The presence of L. monocytogenes in foods such as cheese and milk products represents a significant danger to public health.

The Canadian Food Inspection Agency issued an 11/24/11 health alert notifying residents of Canada of a voluntary recall initiated by the dairy plant, 3903052 Canada Inc., Boisbriand, in Québec. This large recall followed two previous alerts, fairly extensive product testing and a clinical match to a case of listeriosis.

The US Food and Drug Administration (FDA) notified MDPH on 12/28/11 that product was distributed to Cedar Market located in Norwood, MA.  Cedar Market is a retail establishment, which also sold the following products to Bahnan’s located in Worcester, MA.

The recalled products distributed in Massachusetts have the brand name “Fromagerie Marie Kade”.  All cheese products involved bear establishment number 1874. Any Best Before dates up to and including those listed, are affected by the alert. The cheese products that are the subject of the consumer alert in Massachusetts include:

• Akawi Cheese Best Before 08 MAR 2012
• Baladi Cheese Best Before 08 FEB 2012.
• Shinglish Cheese Best Before 07 NOV 2012
• Tresse Cheese Best Before 10 NOV 2012
• Vachekaval Cheese Best Before 10 MAR 2012
• Halloom Best Before 01 MAY 2012
• Moujadale Best Before 04 MAY 2012      

L. monocytogenes is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.  Although healthy individuals may suffer only short-term symptoms, such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, listeria infection can cause miscarriages and still births among pregnant women.

To date, no illnesses have been reported in MA.  MDPH has worked with the US FDA and local officials to embargo and destroy these products and to review inventory records for distribution.

Since the recalled products have not expired, it is possible that consumers may have products in their home. For that reason, MDPH is advising consumers who have purchased products listed to discard them. Consumers with questions may call MDPH Food Protection Program at 617-983-6712.

Canadian notice:  http://www.inspection.gc.ca/english/corpaffr/recarapp/2011/20111124be.shtml
The Canadian website may periodically list expanded products involved in this recall."