The FDA is warning consumers and healthcare professionals that Percussionaire’s December 12, 2023 recall of its High Frequency Transport Phasitron Breathing Circuit Kits has been listed as Class I, the most serious type, because use of the product may lead to major injuries or death.
The recall covers 2,145 devices that were distributed between June 9, 2023 and December 1, 2023.
Designed to facilitate continuous ventilation for patients, the High Frequency Transport Phasitron Breathing Circuit Kit is meant to be paired with Percussionaire high frequency percussive ventilation (HFPV) systems. Typically used in hospital or pre-hospital settings where emergency care is administered, the kit can also be used during transport, within and outside a hospital.
Company officials announced the recall after discovering a defect in the product that causes over-pressurization. The problem is attributed to the manufacture of the Phasitron kit, which required that two parts be pressed together. One component appears to have been angled incorrectly and pressed, causing it to become deformed. The defective part then results in the PEEP (positive end expiratory pressure) valve becoming stuck in a closed position, preventing the valve from being manually released.
Patients receiving ventilation using the High Frequency Transport Phasitron Breathing Circuit Kits, as well as the healthcare providers administering the kits, are advised against use of the affected kits, as they could lead to major health consequences like “lung injury, low blood pressure, collapsed lung, cardiac arrest, and death.”
To date of the FDA recall announcement, the company has received three complaints about the problem, and one report of injury. No deaths have been reported in connection to the recall.
Percussionaire issued an Urgent Field Safety Notice to its distributors and healthcare providers on the day of the announcement, with a list of instructions for both groups:
Distributors:
- Complete the Distributor Acknowledgement form included in the notice and have it returned to Percussionaire.
- Ensure that all end customers also receive the Urgent Field Safety Notice, with the Pre-Use Checklist included.
- Evaluate inventory for any affected lots and return the items as soon as possible.
- Facilitate the return of affected products from end customers
Healthcare Providers:
- Complete the Distributor Acknowledgement form included in the notice and have it returned to Percussionaire.
- Prior to administering the device on a patient, complete the Pre-Check Checklist included in the notice.
- Return all impacted products as soon as possible
U.S.-based customers may direct any recall-related questions to Percussionaire Corporation at 1-800-850-7205.
As the FDA continues to monitor this recall, the agency asks that healthcare professionals and consumers report any adverse reactions or quality issues to its MedWatch program.
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