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
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
The connector may disconnect from the tracheostomy tube during use.