[August 21, 2014]

Smiths Medical Issues Urgent Medical Device Recall of Certain Portex® Endotracheal Tube Holders, 2.5mm and 3.0mm

Smiths Medical, a leading global medical device manufacturer, announced today that it is initiating a nationwide recall of certain lots of Portex® Endotracheal Tube Holders sold as stand-alone products and packaged in intubation kits. The FDA has been made aware of this action.

Smiths Medical is voluntarily recalling these products because a small number of customers have reported difficulty when passing a suction catheter through the Endotracheal Tube when the holder is locked, or have experienced difficulty when locking the holder. These conditions could present a delay in therapy while replacement product is obtained, or could result in an accidental tube extubation if the Endotracheal Tube Holder fastener is loosened in an effort to suction the patient. A copy of the customer notification letter is posted on the Smiths Medical website at www.smiths-medical.com.

In some reports of issues with passing the suction catheter through the Endotracheal Tube, customers were attempting to use 6 Fr suction catheters with 2.5mm Endotracheal Tubes. Smiths Medical recommends the use of 5 Fr suction catheters with 2.5mm Endotracheal Tubes. For a guidance chart on Tracheal Tube/ Suction Catheter sizes, please access the chart at the Smiths Medical website at http://www.smiths-medical.com/plugins/news/2014/aug/urgent-medical-device-recall.html.

Consumers who have the Affected Tube Holders should:

1. Inspect your inventory and segregate any unused affected products (refer to the list below); and
2. Complete and return the Confirmation Form (located at http://www.smiths-medical.com), either by fax at +1-800-621-2590 or by e-mail to: [email protected] within 7 days of receipt of this notice.

Upon receipt of the completed form, a customer service representative will contact you to arrange for exchange of your unused affected inventory for credit or replacement.

Details of Affected Devices:
Portex® Endotracheal Tube Holders, 2.5mm and 3.0mm

Smiths Medical is notifying affected customers via Fedex. Recipients of the Urgent Medical Device Recall Notice who have distributed the affected products to other persons or facilities should promptly forward a copy of the Urgent Medical Device Recall Notice accordingly.

For questions regarding this recall, customers should contact:

Smiths Medical Customer Service (Monday - Friday 8am - 8pm CST)
800-258-5361, Option 1
[email protected]

Customers should report any issues with the Portex® Endotracheal Tube Holders to Smiths Medical's Global Complaints Department at [email protected] or 1-866-216-8806.

Any adverse events that may be related to the use of this product should be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Online at www.fda.gov/MedWatch/report.htm
• Regular Mail; use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm
• Fax 1-800-FDA-0178.

About Smiths Medical
Smiths Medical www.smiths-medical.com is a leading supplier of specialized 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.

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