ICU Medical’s Smiths Medical this week issued an urgent field safety notice for some of its Portex Blue Line siliconized PVC tracheotomy tubes.
The company issued the warning due to an issue related to the neck plate or flange of the Portex Blue Line siliconized PVC tracheotomy tubes. The failure mode can happen during use as a complete or partial detachment of the neck plate from the tracheostomy tube on Portex Blue Line Classic tracheotomy tubes.
If the failure mode occurs, a patient could receive inadequate ventilation and complete dislodgement of the tracheostomy tube. The company said in the warning letter that hypoxia, underdose, cardiopulmonary collapse, bradycardia, hypotension, respiratory arrest, or asphyxia could result from partial or complete detachment of the flange.
Smiths Medical has received five reports of serious injury and no reports of death from this issue.
The devices affected by the urgent notice were manufactured between December 1, 2018, and December 9, 2021. They were distributed in Germany between January 2019 and May 2022. The following products and lot numbers are involved in this issue.
Smiths Medical’s remediation
Smiths Medical issued a global ship hold to ensure any stock held at its distribution center will not be sold and any returned products are not distributed further. The company will provide replacement products or credit to affected customers.
The company recommended customers check all inventory locations for the affected catalog numbers and lot numbers and discontinue use of the Portex Blue Line siliconized PVC tracheotomy tubes. It also requests customers fill out the response form received and acknowledge understanding of the notification.
Distributors of the Portex Blue Line siliconized PVC tracheotomy tubes should forward the urgent field safety notice to customers and request they fill out the response form.
The news of this recall comes days after the FDA labeled one of Smiths Medical’s recalls of some ASD PneuPac paraPAC Plus 300 and 310 Ventilator kits as Class I, the most serious kind. The company said the ventilators may intermittently provide continuous positive gas flow instead of the intended cycling like a human breath when switched to the “Ventilate” operating mode. Smiths Medical labeled this a malfunction that could prevent the ventilator from functioning properly. There have been 177 MDR events reported, of which 8 were serious injuries related to that issue. There have been no reports of death.
