Filter/HME Twinstar Plus

Manufacturer's market surveillance activities revealed cases of increased inspiratory resistance resulting in insufficient ventilation, which may be related to formation of condensate in the filter housing. 

Device is intended exclusively for single patient use no longer than 24 hours. Excessive condensation can significantly shorten the period of use of the device and require the product to be replaced latest after 24 hours. 

Increased resistance carries the risk of desaturation for the patient. Should this hazardous situation encounter, consider the possibility that it may be related to the occlusion of the filter due to condensate. 

The current instructions for use contain warnings related to condensate. However, manufacturer has determined that the instructions can be further improved. Until the revised instructions for use are available customers may continue using the device as long as both airway pressure and volume are permanently monitored and alarm limits for each patient are suitably selected. Change of filter is required in the case of resistance increase.

Recall start date: July 24, 2023