Tracoe Experc Percut Dilation Tracheostomy Set W/Trachatraumatic Inserter
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalogue number |
|---|---|---|
Tracoe Experc Percut Dilation Tracheostomy Set W/Trachatraumatic Inserter |
1100026287 |
461-08-P |
Tracoe Experc Percut Dilation Tracheostomy Set W/Trachatraumatic Inserter |
1100024157 |
424-08 |
Tracoe Experc Percut Dilation Tracheostomy Set W/Trachatraumatic Inserter |
1100024241 |
424-08 |
Tracoe Experc Percut Dilation Tracheostomy Set W/Trachatraumatic Inserter |
1100030719 |
424-08 |
Tracoe Experc Percut Dilation Tracheostomy Set W/Trachatraumatic Inserter |
1100022836 |
423-08 |
Tracoe Experc Percut Dilation Tracheostomy Set W/Trachatraumatic Inserter |
1100030666 |
423-08 |
Issue
Tracoe is issuing a Field Safety Notice as the application bears a very low risk that the silicone sleeve may detach from the guiding catheter when removing the insertion system of the tracheostomy tube. The sleeve may remain in the cannula and block it, requiring an immediate cannula change, or it may slip into the trachea, necessitating immediate bronchoscopy removal. The incidence rate is very low.
Additional information
Details
Tracoe Medical GmbH
Reichelsheimer Str.1/3, Nieder-Olm, Germany, 55268
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