Hudson RCI Large Volume Nebulizer (September 2007)

Teleflex Medical has issued a voluntary recall for specific catalog and lot numbers of the Hudson RCI Large Valume Nebulizer, identified below. This product is used in institutional and homecare settings. The Food and Drug administration has been notified of this action.

There have been reports of a decrease in flow output through the nebulizer adapter which may cause the device to not perform as intended. When used at the higher oxygen concentration settings, this decrease in flow may lower the oxygen concentration inspired by the patient. If the defect is not detected and these devices were used, the decrease in inspired oxygen concentration could compromise a patient's respiratory status.

Signs of decrease flow should be detected by the clinician/caregiver during set up as they will not be able to set the flow meter at the recommended flow rate printed on the adaptor for the prescribed oxygen concentration. The amount of visible aerosol produced at the high oxygen concentrations will also be less than desired. The nebulizers in question are not indicated for delivery of drugs and are intended for use with oxygen and water or saline for humidification. Reduced humidification may cause increased airway obstruction in patients with thich respiratory secretions.

If you have received the product included in the scope of this recall, please take the following actions:

Return all affected product in your possession along with an Acknowledgment & Stock Status Form so that your product can be reconciled with our distribution records.

Your product can be returned to:

Sheldon Medical Supply
21 West Sanilac Avenue
Sandusky, Michigan 48471

Teleflex Medical will provide a replacement product to you in exchange for the defective product as is becomes available.