Sentec/Percussionaire is recalling Phasitron breathing circuit kits after receiving a customer complaint that the venturi component of the kit may stop oscillating during use, resulting in patient oxygen desaturation, according to an FDA alert.

The FDA reports that the risk of failure is “especially high for pediatric patients due to the low pressures that are associated with this component failure.”

The FDA has identified this as a Class I recall, cautioning that use of affected product may cause serious adverse health consequences, including acute respiratory failure, hypoxia, hypercapnia, potential brain damage, heart complications, increased risk of pneumonia, and death.  

No reported injuries or deaths have been reported, the FDA said in the alert.

The Phasitron breathing circuit kit is intended to be used for continuous, controlled ventilation of patients who are unable to breathe on their own. The venturi component of the Phasitron helps with the pulsing flow of air/oxygen to the patient. 

Product Recall Information

  • Product Names/Models and Part Numbers:
    • Phasitron Kit, VDR, Single Patient A50094-D, A50094-D-5PK
      • Unique Device Identifier (UDI): 00849436000259
    • Control Unit Tester A51001-VDR4 
    • VDR W/SWIVEL T SINGLE PATIENT PHASITRON PRT-991 
    • VDR4 HUMIDIFICATION ADAPTER KIT PRT-992 
    • VDR4 Humidification Kit with Cross Tee PRT-993 
  • Lot/Serial Numbers: See full list of affected devices on the FDA website.

What to Do  

  • Closely monitor all patients who are ventilated with Phasitron breathing circuits that may be affected by this issue. 
  • Make sure the venturi component of the Phasitron breathing circuit in use is moving by looking for movement and listening for noise.
  • Do not use any Phasitron breathing circuit that is malfunctioning or does not pass the enhanced pre-check instructions outlined below.

More information is available on the FDA website.