Teleflex Medical Recalls Willy Rusch Tracheostomy Tube Sets
Teleflex Medical is recalling Willy Rusch Tracheostomy Tube Sets because the connector may disconnect from the tube during use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of harm (connector disconnection) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
Teleflex Medical is recalling Willy Rusch GmbH Tracheostomy Tube Sets. The recall involves 1,095 units distributed nationwide in the United States and in Austria, Belgium, France, Germany, Italy, Japan, Poland, and Turkey. The affected lots are 15451, 15291, 15331, 15371, 15501, 15261, 15391, 15421, 15461, and 15491.
The recall is being issued because the connector may disconnect from the tracheostomy tube during use. This product is used for the cannulation of tracheotomised patients, particularly in cases involving a narrow tracheostoma and narrow-lumen tracheas.
Healthcare providers and patients should stop using the affected tracheostomy tube sets and contact Teleflex Medical for further instructions.
The recalled product
- 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.
- Manufacturer
- Teleflex Medical
- Hazard
- Affected units
- 1,095
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- Lot - 15451
- 15291
- 15331
- 15371
- 15501
- 15261
- 15391
- 15421
- 15461
- 15491
Distribution
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