Centurion Medical Products Premie Pack and Full Term Meconium Pack Recall

The FDA has announced the expansion of a September recall for Portex pediatric tracheal tubes to include certain lots of Centurion Medical Products Premie Packs and Full Term Meconium Packs.

The FDA announced the expanded pediatric tracheal tube recall on Tuesday, indicating that the Centurion Medical Products kits have been found to contain Portex uncuffed pediatric-sized tracheal tubes that were recalled on September 10. The recall is a Class I recall, meaning that use of the product carries a reasonable probability of serious injury or death. The recalled kits are used to treat infants and newborns. No reports involving death or serious injury have been associated with the defective tracheal tubes or the recalled kits.

The Portex pediatric tubes were recalled due to a potential defect that could cause some of the tubes to have internal diameters that are smaller than they are supposed to be. This could result in difficulty clearing secretions from the device or the airway, potentially leading to an airway obstruction.

Eight lots of Centurion Medical Products Premie Packs, kit code LM 110, and nine lots of Full Term Meconium Packs, kit code LM 115, have been found to contain the defective tracheal tubes and have been recalled. The lot numbers for the recalled Premie Packs are 901087, 903267, 907307, 910297, 901218, 908258, 2009020990, and 2009022390. The lot numbers for the recalled Meconium Packs are 01297, 07097, 09107, 12037, 06028, 2008091501, 2008120801, 2009033001, and 2009062201. The packs were made and distributed from January through September 2009.

The initial recall applies to several variations of Portex Uncuffed Pediatric-Sized Tracheal Tubes made before September 2009, including sizes of 2.5, 3.0 and 3.5mm. manufactured by Smiths Medical.

Smiths Medical is instructing all heath care professionals and other customers to return any unused tracheal tubes affected by the recall. However, the company indicates that there is no evidence that it is necessary to remove tubes currently in use with a patient, and recommends that customers use a company-supplied Guidance Chart for suction catheter sizes if suctioning of one of the affected tracheal tubes is required.

Centurion Medical Products has notified sales representatives and customers of the problem and the devices have been removed from inventory. Any health care professional or patient that experiences an adverse reaction due to the recalled kits should contact the FDA’s MedWatch Adverse Event Reporting program.