Reported Oct 22, 2025 · Ongoing
Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE…
Percussionaire Corporation
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Percussionaire Corporation · 130 Mcghee Rd Ste 109 · Sandpoint, ID · 83864-8409
Is this the product you have?
- Phasitron 5, IPV In-Line Valve, (Intrapulmonary
- Percussive Ventilation) REFP5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve Sentec Instructions for Use
- Lot codes and dates
- UDI-DI00849436000723
- Lots
240326250116240418250324240610250616240620241121230612240826WO04884241118WO06020241203WO05019250111WO04827WO04756. Instructions for Use P20020 Rev F
- Amount recalled
- 59160
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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