The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has issued a warning over The Great Ormond Street GOS tracheostomy cannula set, stating that the tube is too straight due to a manufacturing error.
Teleflex Medical, the manufacturer of the product, has initiated a product recall, and is not aware of any incidents of injury related to this issue.
According to MHRA, if the tube is too straight, it can lead to damage to the tracheal wall during insertion or overtime following insertion.
MHRA has asked the supplies departments and all staff responsible replacement for tracheostomy procedures and care to identify and quarantine the affected devices.
The unused affected devices are to be returned to Teleflex.
If the patient has one of the affected devices in situ, a local risk assessment is to be done to determine if elective replacement of the tube is necessary.
Teleflex’s tracheostomy cannula set is used to maintain an open airway and is inserted into a patient’s trachea surgically via the neck.