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Recall -- Firm Press Release

 

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

 

Smiths Medical Issues Urgent Device Recall Of Portex® Pediatric-Sized Tracheal Tubes

 

Company Contact: 
Robert Hanvik 
651-628-7613

 

FOR IMMEDIATE RELEASE – September 10, 2009 –   ST. PAUL, Minn.- 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 a reasonable probability of 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 customers, Smiths Medical is instructing
them to return all unused Tracheal Tubes. 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
fax at 1-603-355-8157 to: Recall Administrator, Regulatory Affairs, Smiths
Medical ASD, Inc.
Following these steps, customers will be provided with specific directions
regarding how to return unused product.
The products affected by this recall have the following Product Codes:
 

Product codeProduct description
100/105/025Portex® Tracheal Tube, Oral/Nasal, Ivory
100/105/030Portex® Tracheal Tube, Oral/Nasal, Ivory
100/105/035Portex® Tracheal Tube, Oral/Nasal, Ivory
100/111/025Portex® Tracheal Tube, Oral/Nasal, Siliconized
100/111/030Portex® Tracheal Tube, Oral/Nasal, Siliconized
100/111/035Portex® Tracheal Tube, Oral/Nasal, Siliconized
100/126/025Portex® Tracheal Tube, Cut to Length, Oral, Siliconized
100/126/030Portex® Tracheal Tube, Cut to Length, Oral, Siliconized
100/126/035Portex® Tracheal Tube, Cut to Length, Oral, Siliconized
100/127/025Portex® Tracheal Tube, Oral/Nasal, Murphy Eye, Clear
100/127/030Portex® Tracheal Tube, Oral/Nasal, Murphy Eye, Clear
100/127/035Portex® Tracheal Tube, Oral/Nasal, Murphy Eye, Clear
100/134/030Portex® Polar Preformed Tracheal Tube, South Oral, Murphy
Eye, Clear
100/134/035Portex® Polar Preformed Tracheal Tube, South Oral, Murphy
Eye, Clear
100/141/025Portex® Tracheal Tube, Oral/Nasal, Murphy Eye, Siliconized
100/141/030Portex® Tracheal Tube, Oral/Nasal, Murphy Eye, Siliconized
100/141/035Portex® Tracheal Tube, Oral/Nasal, Murphy Eye, Siliconized


If an 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
Tracheal Tube cUlTently 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 Tracheal Tubes to other
persons or facilities should promptly forward a copy ofthe 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 1-800FDA-
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.

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