Smiths Medical, a leading global medical device manufacturer, announced today that it is initiating a nationwide recall of certain lots of Portex Endotracheal Tube Holders sold as stand-alone products and packaged in intubation kits. The FDA has been made aware of this action.
Smiths Medical is voluntarily recalling these products because a small number of customers have reported difficulty when passing a suction catheter through the Endotracheal Tube when the holder is locked, or have experienced difficulty when locking the holder.
These conditions could present a delay in therapy while replacement product is obtained, or could result in an accidental tube extubation if the Endotracheal Tube Holder fastener is loosened in an effort to suction the patient.
In some reports of issues with passing the suction catheter through the Endotracheal Tube, customers were attempting to use 6 Fr suction catheters with 2.5mm Endotracheal Tubes. Smiths Medical recommends the use of 5 Fr suction catheters with 2.5mm Endotracheal Tubes.
Smiths Medical is notifying affected customers via FedEx. Recipients of the Urgent Medical Device Recall Notice who have distributed the affected products to other persons or facilities should promptly forward a copy of the Urgent Medical Device Recall Notice accordingly.