Percussionaire recalled 59,160 Phasitron 5 In-Line Valves on September 17, 2025. The valves may leak when used with ventilators, posing a high risk of respiratory failure. Consumers should stop using the product immediately and follow recall instructions.
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 recalled Phasitron 5 In-Line Valve, with reference numbers P5-TEE-20 (pack of 20) and P5-TEE (individual), was distributed worldwide. The affected lots include multiple models such as 240326 and 250111.
The in-line valve may leak when used with ventilators, especially in neonates and infants. This defect can lead to respiratory acidosis, hypoxemia, or respiratory failure.
No specific incidents or injuries have been reported to date. However, the risk of serious complications in vulnerable populations is significant.
Stop using the device immediately. Follow the manufacturer’s recall instructions and contact Percussionaire Corporation or your healthcare provider for guidance.
For more information, contact Percussionaire Corporation. Visit the recall notice at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0031-2026.
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