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:
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,
Customers should report any issues with the Portex® Endotracheal Tube
Holders to Smiths Medical's Global Complaints Department at firstname.lastname@example.org
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.
About Smiths MedicalSmiths 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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