|Recall Class:||Class I|
|September 22, 2009|
|Product:||Premie Pack, Kit Code LM 110 and Full Term Meconium Pack, Kit Code LM115
These products were distributed from January 1, 2007 through September 22, 2009.
See Related Class I Recall: Smiths Medical ASD, Inc., Portex Uncuffed Pediatric-Sized Tracheal Tubes (sizes 2.5, 3.0, and 3.5 mm)
|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:||Centurion Medical Products
301 Catrell Drive
Howell, Michigan 48843-1703
|Reason for Recall:||The manufacturer of the pediatric tracheal tubes used in these kits recalled them because they were manufactured with an internal diameter smaller than indicated on the label, which could result in an inability to remove secretions and cause partial or complete blockage of the airway and the inability to ventilate the patient.|
The company may be contacted at 1-800-248-4058 (Eastern Time).
For more information, see Useful Link below.
The company notified the sales representative about the recall on September 22, 2009 by email. The single customer was notified by letter which was dated September 23, 2009. The product was removed from the customer’s inventory on September 28, 2009 and returned to the recalling firm.
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.