Percussive ventilation valves recalled over leak risk in small patients
Percussionaire is recalling 59,160 Phasitron 5 IPV in-line valves whose pressure relief seal may leak when used with a ventilator, and is warning against use in neonates and infants.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: Scored 5 because the FDA classified this recall as Class I, which the rubric assigns the Critical tier.
Plain-English summary
The Phasitron 5 IPV In-Line Valve for intrapulmonary percussive ventilation, REF P5-TEE-20 (pack of 20) and P5-TEE (individual), supplied with In-Line Valve Sentec Instructions for Use, is being recalled with an instructions-for-use update.
The in-line valve with pressure relief seal may leak when used with a ventilator. The firm states the device should not be used in neonates or infants, or with target tidal volumes under 50 mL or in patients under 10 kg, because those patients are at high risk of cardiopulmonary or neurological compromise from unrecognized hypoventilation. The update also covers continued use in other patients pending a design update. A leak may cause respiratory acidosis, hypoxemia or respiratory failure.
The recall covers 59,160 units carrying UDI-DI 00849436000723, across lots including 240326, 250116, 240418, 250324, 240610, 250616, 240620, 241121, 230612 and 240826. Distribution was worldwide, including US nationwide and Russia, Japan, Switzerland, Canada, Qatar, Chile and South Africa. The FDA has classified the recall as Class I.
Clinicians should follow the updated instructions for use and the stated patient restrictions.
The recalled product
- Product
- Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve Sentec Instructions for Use
- Manufacturer
- Percussionaire Corporation
- Affected units
- 59,160
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (18)
- UDI-DI: 00849436000723. Lots: 240326
- 250116
- 240418
- 250324
- 240610
- 250616
- 240620
- 241121
- 230612
- 240826
- WO04884
- 241118
- WO06020
- 241203
- WO05019
- 250111
- WO04827
- WO04756. Instructions for Use P20020 Rev F
Distribution
Distributed nationwide across the United States.
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