Smiths Medical ASD, Inc., Portex Uncuffed Pediatric-Sized Tracheal Tubes (sizes 2.5, 3.0, and 3.5 mm)
|Recall Class:||Class I|
|August 25, 2009|
Portex Uncuffed Pediatric Pediatric-Sized Tracheal Tubes (sizes 2.5, 3.0, and 3.5 mm)
The devices affected by this recall have the following product codes:
|Use:||A tracheal tube is inserted through the nose or mouth into a patient’s windpipe in order to ensure that the airway is not obstructed and that oxygen or anesthesia reaches the lungs. These tubes are used in both adults and pediatric patients, but not newborns or infants.|
|Recalling Firm:||Smiths Medical ASD, Inc.
10 Bowman Drive
Keene, New Hampshire 03431-5043
|Reason for Recall:||Some of the products were manufactured with internal diameters smaller than indicated on the labeling. The clinician may have difficulty passing through or withdrawing the suction catheter. Use of this device may also include the inability to remove secretions from the device and from the patient’s airway. This may result in partial or complete obstruction of the patient’s airway and the inability to ventilate the patient. In addition, this defect may increase airway resistance and compromise the ability to ventilate the patient.|
|Public Contact:||Customers may contact the company at 1-800-348-6064, prompt 4, ext. 2273, Monday-Friday, 7:00 AM to 3:30 PM, ET.|
|FDA District:||New England|
On August 24, 2009, the company sent a notice with an updated Guidance Chart. This chart provided medical staff with guidance on using the appropriate suction catheter size with a specific tracheal tube size. The company requested their customers to:
If an affected tracheal tube is currently in use with a patient, there is no evidence that the removal of the tracheal tube is necessary.
If suctioning of an affected tracheal tube in use is required, the company recommends that customers refer to the company-supplied Guidance Chart for suction catheter sizes at http://www.smiths-medical.com.
For more information, see Useful Links below.
Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.
Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.