FDAFDA · Food and drugs·Recall number Z-0044-2017
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.
Published October 26, 2016 · Recall initiated: August 26, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The connector may disconnect from the tracheostomy tube during use.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Teleflex Medical
- Distributor
- Worldwide Distribution: US (nationwide) to CA and countries of: Austria, Belgium, France, Germany, Italy, Japan, Poland, and Turkey.
- Lot
- Lot - 15451, 15291, 15331, 15371, 15501, 15261, 15391, 15421, 15461, 15491
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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