PlainRecalls
FDA Devices Critical Class I Terminated

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.

Reported: October 26, 2016 Initiated: August 26, 2016 #Z-0044-2017

Product Description

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.

Reason for Recall

The connector may disconnect from the tracheostomy tube during use.

Details

Recalling Firm
Teleflex Medical
Units Affected
1095 units
Distribution
Worldwide Distribution: US (nationwide) to CA and countries of: Austria, Belgium, France, Germany, Italy, Japan, Poland, and Turkey.
Location
Morrisville, NC

Frequently Asked Questions

What product 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.. Recalled by Teleflex Medical. Units affected: 1095 units.
Why was this product recalled?
The connector may disconnect from the tracheostomy tube during use.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 26, 2016. Severity: Critical. Recall number: Z-0044-2017.