Teleflex Medical recalls Willy Rusch GmbH Tracheostomy Tube Set Cannulation of tracheotomised patients, particularly in the case of a narrow tra…

Recall date

August 26, 2016

Source

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

Recall number

Z-0044-2017

FDA classification

Class I

Brand / firm

Teleflex Medical

Sold / distributed

Worldwide Distribution: US (nationwide) to CA and countries of: Austria, Belgium, France, Germany, Italy, Japan, Poland, and Turkey.

Why it was recalled

The connector may disconnect from the tracheostomy tube during use.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Willy Rusch GmbH Tracheostomy Tube Set Cannulation of tracheotomised patients, particularly in the case of a narrow tracheostoma and narrow-lumen tracheas. When using cannulas with curr. For short term intermittent inflation.