SMITHS MEDICAL ISSUES URGENT DEVICE RECALL OF PORTEX® PEDIATRIC-SIZED TRACHEAL TUBES

FOR IMMEDIATE RELEASE – ST. PAUL, Minn. – 10 September 2009 – Smiths Medical announced that it is initiating a nationwide voluntary recall of Portex® Uncuffed Pediatric-Sized Tracheal Tubes (sizes 2.5, 3.0 and 3.5 mm) manufactured before September 2009.

Description of the Issue
A small number of tubes were manufactured with internal diameters slightly smaller than indicated on the labeling, which may create the potential for the clinician to experience difficulty passing through or withdrawing the suction catheter. The health consequences that may result from use of the defective device include the inability to remove secretions from the device and from the patient’s airway, which may result in partial or complete obstruction of the airway and an inability to ventilate the patient. In addition, this defect may increase airway resistance and compromise the ability to ventilate the patient. There is reasonable probability of or serious injury and/or death. To date, the company has not received any reports of death or permanent injury related to this issue.

Recommended Action to be Taken by the User
In a Recall Notice sent directly to all affected customers, Smiths Medical is instructing them to return all unused affected Tracheal Tubes within its expiration date. This requires customers to take the following steps:

• Review inventory and segregate any unused product manufactured before September 2009 and within its expiration date.
• Complete and return a Confirmation Form (included with the Recall Notice) by mail to: Recall Administrator, Regulatory Affairs, Smiths Medical ASD, Inc., 10 Bowman Drive, Keene, NH 03431 or by fax at 1-603-355-8157.

Following these steps, customers will be provided with specific directions regarding how to return unused affected product.

The products affected by this recall have the following Product Codes:

If an affected Tracheal Tube is currently in use with a patient, there is no evidence to suggest that immediate removal of the Tracheal Tube is necessary. If suctioning of an affected Tracheal Tube currently in use is required, Smiths Medical recommends that customers refer to a company-supplied Guidance Chart for suction catheter sizes, available at www.smiths-medical.com. Clinicians who choose to use larger-than-recommended suction catheters should base this decision on sound clinical judgment and use caution, to assure the suction catheter readily passes through and can be readily withdrawn from the Tracheal Tube.

Recipients of the Recall Notice who have distributed affected Tracheal Tubes to other persons or facilities should promptly forward a copy of the Recall Notice to them.

For questions regarding this Recall Notice, customers should contact:

Charlotte Veysey
Regulatory Affairs
Smiths Medical ASD, Inc.
10 Bowman Drive
Keene, NH 03431 USA
Tel: 1-800-348-6064, prompt 4, ext 2273
Fax: 603-355-8157
E-mail: Charlotte.veysey@smiths-medical.com  

Customers should report any issues with the Portex® Tracheal Tubes to Smiths Medical’s Technical Services Complaints Department at 1-866-216-8806.

Any adverse reactions experienced with the use of these products and/or quality problems may also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch Web site at www.fda.gov/medwatch.

About Smiths Medical
Smiths Medical www.smiths-medical.com is a leading supplier of specialist medical devices and equipment for global markets, focusing on the medication delivery, vital care and safety devices market segments. It is part of Smiths Group www.smiths.com, a global leader in applying advanced technologies for markets in threat and contraband detection, energy, medical devices, communications and engineered components. Smiths Group employs around 22,000 people in more than 50 countries.

CONTACT:
Robert Hanvik
Smiths Medical
Tel: +1.651.628.7613
Mobile: +1.612.812.2433