Centurion Premie and Meconium Packs RecalledNov 5, 2009 | Parker Waichman LLP
Centurion Medical Products Premie Pack and Meconium Pack Pediatric Tracheal Tubes have been recalled, the U.S. Food and Drug Administration (FDA) just announced. The tubes were manufactured with an internal diameter smaller than that indicated on label.
The recall has been directed to anesthesiology healthcare professionals and hospital risk managers and both Centurion Medical Products and the FDA have notified healthcare professionals about the Class I recall that involves Premie Pack, Kit Code LM 110 and Full-Term Meconium Pack, Kit Code LM115. 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.
The pediatric tracheal tubes used in these kits, which were manufactured with an internal diameter smaller than indicated on the label, 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 recalled products were distributed from January 1, 2007 through September 22, 2009.
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.
The FDA indicated that the following models and lots are involved in the recall:
Model/Product Code: These are the Portex uncuffed pediatric sized tracheal tubes which were subject to a prior Class I recall with Smiths Medical:
• 2.5 mm product code 100/105/025
• 3.0 mm product code 100/105/030
• 3.5 mm product code 100/105/035
• 2.5 mm product code 100/111/025
• 3.0 mm product code 100/111/030
• 3.5 mm product code 100/111/035
• 2.5 mm product code 100/126/025
• 3.0 mm product code 100/126/030
• 3.5 mm product code 100/126/035
• 2.5 mm product code 100/141/025
• 3.0 mm product code 100/141/030
• 3.5 mm product code 100/141/035.
Lot/Serial Numbers: These kits contain Portex uncuffed pediatric sized tracheal tubes which were subject to a prior Class I recall with Smiths Medical:
• Premie Pack: 901087,Ã¢â‚¬Â¨903267,Ã¢â‚¬Â¨907307,Ã¢â‚¬Â¨910297,Ã¢â‚¬Â¨901218,Ã¢â‚¬Â¨908258,Ã¢â‚¬Â¨2009020990,Ã¢â‚¬Â¨2009022390
• Full Term Meconium Pack: 01297,Ã¢â‚¬Â¨07097,Ã¢â‚¬Â¨09107,Ã¢â‚¬Â¨12037,Ã¢â‚¬Â¨06028,Ã¢â‚¬Â¨2008091501,Ã¢â‚¬Â¨2008120801,Ã¢â‚¬Â¨2009033001,Ã¢â‚¬Â¨2009062201
Centurion Medical Products of Howell, Michigan can be reached toll-free at 1-800-248-4058 (Eastern Time).