Drugs / Medicines Recalls and Alerts

Date: 11/4/2009 1:59:24 PM

Centurion Medical Products - Premie Pack and Meconium Pack - Recall

REASON: The pediatric tracheal tubes used in these kits 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.

distribution: nationwide.

Audience: Anesthesiology healthcare professionals, hospital risk managers

[Posted 11/04/2009] Centurion Medical Products and FDA notified healthcare professionals about a Class I recall of Premie Pack, Kit Code LM 110 and Full Term Meconium Pack, Kit Code LM115. The pediatric tracheal tubes used in these kits 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. These products were distributed from January 1, 2007 through September 22, 2009.

[11/04/2009 - Recall Notice - FDA]

Related MedWatch Alert:

[09/21/2009 - Portex Uncuffed Pediatric-Sized Tracheal Tubes]

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