Percussionaire is recalling its High Frequency Transport Phasitron Breathing Circuit Kits due to a product defect that causes over-pressurization, according to a medical device recall notice from the US FDA.
Percussionaire was acquired by Sentec in September 2022.
According to the FDA alert, there are two parts of the Phasitron kit that must be pressed together during manufacturing. If one part is angled incorrectly and pressed, the part can become deformed. This causes the positive end expiratory pressure (PEEP) valve to be stuck in the closed position. When the valve is stuck, there is no way to manually release the valve.
The use of the affected Phasitron kits may cause serious adverse health consequences, including lung injury, low blood pressure, collapsed lung, cardiac arrest, and death. There have been three complaints regarding this device issue, and one injury. There have been no reports of death.
The FDA has identified this as a Class I recall, the most serious type of recall.
The High Frequency Transport Phasitron Breathing Circuit Kit is used for continuous ventilation of patients. The kit is intended to be used with Percussionaire high frequency percussive ventilation systems for either hospital or prehospital use where emergency care is being provided. The kit can also be used for transport within a hospital or outside a hospital.
Recalled Product
- Product names: High Frequency Transport Phasitron Breathing Circuit Kit (A50605-D)
- Product codes: See recall database entry
- Distribution dates: June 9, 2023, to Dec 1, 2023
- Devices recalled in the US: 2,145
- Date initiated by firm: Dec 12, 2023
On Dec 12, 2023, Percussionaire sent all affected customers an Urgent Field Safety Notice to distributors and health care providers. The letter requested distributors to:
- Complete and return the distributor acknowledgement form included along with the notice
- Send Urgent Field Safety Notice containing Pre‐Use Checklist to end customers
- Prioritize the return of affected lots in stock
- Support end customers returning affected products
The letter requested health care providers to:
- Complete and return the acknowledgement form included along with notice
- Complete Pre‐Check Checklist (included with notice) prior to patient use
- Prioritize the return of all impacted product
Customers in the US with questions about this recall should contact Percussionaire at 1-800-850-7205.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or fax.