CanadaWhat's being recalled
Companies: Tracoe Medical GmbH, Reichelsheimer Str.1/3, Nieder-Olm, Germany, 55268.
How to identify it
Affected products: Tracoe Experc Percut Dilation Tracheostomy Set W/Trachatraumatic Inserter; Lot or serial number: 1100026287; Model or catalogue number: 461-08-P
Affected products: Tracoe Experc Percut Dilation Tracheostomy Set W/Trachatraumatic Inserter; Lot or serial number: 1100024157; Model or catalogue number: 424-08
Affected products: Tracoe Experc Percut Dilation Tracheostomy Set W/Trachatraumatic Inserter; Lot or serial number: 1100024241; Model or catalogue number: 424-08
Affected products: Tracoe Experc Percut Dilation Tracheostomy Set W/Trachatraumatic Inserter; Lot or serial number: 1100030719; Model or catalogue number: 424-08
Affected products: Tracoe Experc Percut Dilation Tracheostomy Set W/Trachatraumatic Inserter; Lot or serial number: 1100022836; Model or catalogue number: 423-08
Affected products: Tracoe Experc Percut Dilation Tracheostomy Set W/Trachatraumatic Inserter; Lot or serial number: 1100030666; Model or catalogue number: 423-08
The hazard
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.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)