News

This week, Smiths Medical, a division of ICU Medical, issued an urgent field safety notice regarding certain Portex Blue Line siliconized PVC tracheotomy tubes.

The company issued the notice due to a concern regarding the neck plate or flange of these tubes. The problem may involve a complete or partial detachment of the neck plate from the tracheostomy tube, specifically affecting Portex Blue Line Classic tracheotomy tubes.

If this detachment occurs, it could lead to insufficient ventilation and complete dislodgement of the tracheostomy tube. Potential consequences highlighted in the warning letter include hypoxia, underdose, cardiopulmonary collapse, bradycardia, hypotension, respiratory arrest, or asphyxia due to partial or complete detachment of the flange.

Smiths Medical has received reports of five serious injuries related to this issue, but no reports of death.

The affected devices were manufactured between December 1, 2018, and December 9, 2021, and were distributed in Germany between January 2019 and May 2022. The impacted products and lot numbers are specified below.

In response to this safety concern, Smiths Medical has implemented several measures. They have initiated a global ship hold to prevent the sale of any affected stock at their distribution center and to ensure that returned products are not redistributed. Affected customers will be provided with replacement products or credit.

The company advises customers to thoroughly check all inventory locations for the affected catalog numbers and lot numbers and discontinue the use of the Portex Blue Line siliconized PVC tracheotomy tubes. Additionally, they request customers to complete the response form provided to acknowledge their understanding of the notification.

Distributors of the Portex Blue Line siliconized PVC tracheotomy tubes are instructed to forward the urgent field safety notice to customers and ensure they complete the response form.

This recall follows shortly after the FDA classified one of Smiths Medical’s recalls of certain ASD PneuPac paraPAC Plus 300 and 310 Ventilator kits as Class I, indicating the most serious level of concern. The issue identified with these ventilators involves intermittent continuous positive gas flow instead of the intended cycling like a human breath when switched to the “Ventilate” operating mode. Smiths Medical has termed this a malfunction that could impair the ventilator’s functionality. There have been 177 Medical Device Reports (MDRs) related to this issue, including 8 serious injuries, but no reported deaths.