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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.

FDA Recall Z-0044-2017 · Posted 2016-10-18

Recalling FirmTeleflex Medical
Recall StatusTerminated
Product CodeJOH
Date Initiated2016-08-26
Date Terminated2017-03-21
Product Quantity1095 units

Reason for Recall

The connector may disconnect from the tracheostomy tube during use.

Firm 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.

Root Cause

Use error

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K964056RUSCH ULTRA TRACHEOFLEX FENESTRATED KIT CUFFED,UNCUFFED/ RUSCH TRACHEOFLEX TRACHEOSTOMY KIT UNCUFFED STERILERusch Intl. · 1997-10-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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