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Recall Observatory FDA recall evidence

Device 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.

Z-0044-2017

August 26, 2016

Class I

Product summary

Firm
Teleflex Medical
Event
Event 75053
Status
Terminated
Classification
Class I
Quantity
1095 units
Official record key
device-enforcement:Z-0044-2017

Official wording

Reason: The connector may disconnect from the tracheostomy tube during use.

Code information: Lot - 15451, 15291, 15331, 15371, 15501, 15261, 15391, 15421, 15461, 15491

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The connector may disconnect from the tracheostomy tube during use.