Recall Z-0044-2017— Teleflex Medical

Name: FDA recall Z-0044-2017
Creator: U.S. Food and Drug Administration
Published: 2016-08-26

Class I · Terminated

Class I FDA medical device recall by Teleflex Medical, initiated 2016-08-26, terminated 2017-03-21. It names one FDA 510(k) clearance: K964056. Product: 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: The connector may disconnect from the tracheostomy tube during use..

Recalling firm: Teleflex Medical
Classification: Class I
Status: Terminated
Initiated: 2016-08-26
Terminated: 2017-03-21
Firm location: Morrisville, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K964056 — RUSCH ULTRA TRACHEOFLEX FENESTRATED KIT CUFFED,UNCUFFED/ RUSCH TRACHEOFLEX TRACHEOSTOMY KIT UNCUFFED STERILERusch Intl.·cleared 1997-10-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.