Breit Drescher & Imprevento Blog

Defective Protex Pediatric-Sized Tracheal Tubes Recalled By FDA

On September 10, the US Food & Drug Administration (FDA) posted a voluntary recall via a press release for a number of Portex tracheal tube products. The recall release says that some of the products manufactured by Protex "were manufactured with internal diameters slightly smaller than indicated on the labeling, which may create the potential for the clinician to experience difficulty passing through or withdrawing the suction catheter."

The FDA recall urges those who have purchased the Portex Pediatric-Sized Tracheal Tubes to review their inventory for the possibly defective products, and to return the unused product to the manufacturer, Smiths Medical, along with some paperwork. The return of the faulty medical devices is recommended, not required.

The recall also stated that if the tracheal tube is already in use with a patient and does not seem to be causing any problems, there is no reason to remove the medical product.