Recall Monitor
Health Products

Tracoe Experc Percut Dilation Tracheostomy Set W/Trachatraumatic Inserter

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Anaesthesiology
Product: Tracoe Experc Percut Dilation Tracheostomy Set W/Trachatraumatic Inserter
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
Tracoe Experc Percut Dilation Tracheostomy Set W/Trachatraumatic Inserter1100026287461-08-P
Tracoe Experc Percut Dilation Tracheostomy Set W/Trachatraumatic Inserter1100024157424-08
Tracoe Experc Percut Dilation Tracheostomy Set W/Trachatraumatic Inserter1100024241424-08
Tracoe Experc Percut Dilation Tracheostomy Set W/Trachatraumatic Inserter1100030719424-08
Tracoe Experc Percut Dilation Tracheostomy Set W/Trachatraumatic Inserter1100022836423-08
Tracoe Experc Percut Dilation Tracheostomy Set W/Trachatraumatic Inserter1100030666423-08

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.

Get told about the next health product recall.
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