Z-0044-2017Class I

Willy Rusch GmbH Tracheostomy Tube Set Cannulation of tracheotomised patients, particularly in the case of a...

Name: Z-0044-2017 Willy Rusch GmbH Tracheostomy Tube Set Cannulation of tracheotomised patients, particularly in the case of a...
Creator: Teleflex Medical
Published: 2016-08-26
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2016-08-26 / Terminated

FDA source

Teleflex Medical began a recall of Willy Rusch GmbH Tracheostomy Tube Set Cannulation of tracheotomised patients, particularly in the case of a narrow tracheostoma and narrow-lumen tracheas... on 2016-08-26. FDA classified it as Class I and gives the reason as "The connector may disconnect from the tracheostomy tube during use". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0044-2017
Classification: Class I
Status: Terminated
Initiated: 2016-08-26
Posted: 2016-10-18
Terminated: 2017-03-21
Recalling firm: Teleflex Medical
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.
Product code: JOH Tube Tracheostomy And Tube Cuff
Reason for recall: The connector may disconnect from the tracheostomy tube during use.
FDA root cause: Use error
Action: Teleflex sent an Urgent Field Safety Notice dated August 26, 2016, to all affected consignees. The letter requested that consignees cease use and distribution of stock, quarantine immediately, and return the product. Also, the letter requested a sub-recall if the product had been further distributed. The letter included an Acknowledgement Form which is to be returned. Customers with questions were instructed to contact their local sales representative or Customer Service. For questions regarding this recall call 610-378-0131.
Quantity in commerce: 1095 units
Distribution: Worldwide Distribution: US (nationwide) to CA and countries of: Austria, Belgium, France, Germany, Italy, Japan, Poland, and Turkey.
Product codes and lots: Lot - 15451, 15291, 15331, 15371, 15501, 15261, 15391, 15421, 15461, 15491

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0044-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0044-2017	Class I	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-18

Product code JOH

K964056Class IIRusch Ultra Tracheoflex Fenestrated Kit Cuffed,uncuffed/ Rusch Tracheoflex Tracheostomy Kit Uncuffed SterileRusch Intl. / cleared 1997-10-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)