Percussionaire recalled 59,160 Phasitron 5 IPV In-Line Valve sets worldwide after an IFU update flagged a pressure-relief leak when used with ventilators. The defect endangers neonates and infants and patients under 10 kg with tidal volumes under 50 mL. Healthcare providers should halt use immediately.
IFU update; in-line valve, with pressure relief seal may leak when used with ventilator; don't use in neonates/infants, with target tidal volumes less-than50mL or less-than10kg- at high risk of cardiopulmonary/neurological compromise due to unrecognized hypoventilation, updates for continued use in others before design update; leak may cause respiratory acidosis, hypoxemia, or respiratory failure.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Percussionaire Corporation or your healthcare provider for instructions. Notification method: Letter
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The Phasitron 5 IPV In-Line Valve is used in intrapulmonary percussive ventilation systems. It is integrated into medical devices used by patients needing respiratory support.
A leaked valve during ventilation can cause inadequate ventilation leading to respiratory acidosis, low oxygen levels, and potential respiratory failure.
This recall is not described as part of a broader industry pattern in the provided data.
The recall affects patients and healthcare providers worldwide who rely on this component for ventilation. Immediate action could prevent serious complications and potential life-threatening outcomes.
Use the FDA recall page linked in enforcement reports for official identifiers and instructions.
Recall remedy is via manufacturer instructions and notification by letter. Specific replacement or refund timing is not provided.
Keep copy of recall letter, authenticate device IDs, photograph labels, record communications with manufacturers and clinicians.
Model numbers include P5-TEE-20 and P5-TEE. UDI-DI 00849436000723. Additional model codes: 240326, 250116, 240418, 250324, 240610, 250616, 240620, 241121, 230612, 240826, WO04884, 241118, WO06020, 241203, WO05019, 250111, WO04827, WO04756. Worldwide distribution with US nationwide and other countries listed in the recall.
No specific incident counts are provided in the source document.
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