Teleflex, Inc. recalls R¿SCH Curved Reinforced Endotracheal Tube: Rusch Reinforced Endotracheal Tube is designated for oral or nasal intubatio…

Recall date

December 12, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1124-2015

FDA classification

Class II

Brand / firm

Teleflex, Inc.

Sold / distributed

Nationwide Distribution

Why it was recalled

Teleflex Medical has issued an advisory notification for the RUSCH Curved Reinforced Endotracheal Tube because of a discrepancy between the labeled cuff diameter and the actual cuff diameter. The actual product cuff diameter meets required specification.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

R¿SCH Curved Reinforced Endotracheal Tube: Rusch Reinforced Endotracheal Tube is designated for oral or nasal intubation and are indicated for airway management. The product may be used to reduce the potential for kinking whenever an unusual positioning of the head or neck is required following intubation.