CanadaCuffed endotracheal tubes (Sunmed Holdings, LLC, model/catalogue 1-7333-25; lot numbers 2108011462 and 2603010274) are affected: the 6FR suction catheter may not pass smoothly through the 2.5 mm tube size. This can prevent airway suctioning and may lead to reintubation; two complaints were reported in the United States, one of which required reintubation and no serious patient harm has occurred. Contact the manufacturer for additional information.
What's being recalled
Companies: Sunmed Holdings, Llc Also Trading As Sunmed Llc, 2710 Northridge Dr Nw, Grand Rapids, Michigan, United States, 49544.
How to identify it
Affected products: Endotracheal Tube, Cuffed; Lot or serial number: 2108011462; Model or catalogue number: 1-7333-25
Affected products: Endotracheal Tube, Cuffed; Lot or serial number: 2603010274; Model or catalogue number: 1-7333-25
The hazard
The 6FR suction catheter could not pass smoothly through the 2.5mm sizes of cuffed tracheal tube. This may lead to reintubations if the airway is unable to be suctioned.
To date, there have been two complaints reported from united states customers where one required reintubation. No serious patient harm has occurred.
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)