Reported Nov 6, 2024 · Ongoing

Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to…

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?

  • Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provide airway clearance therapy
Lot codes and dates
  • Model NumbersP5-10
  • P5-HC P5-UC-10 UDI-DI codesLot
  • Numbers
    • 240321
    • 240329
    • 240412
    • 240430
    • 240509
    • 240516
    • 240614
    • 240625
    • 240627
Amount recalled
43,830 devices

Where it was sold

Why it was recalled

Stop using this product now

As a result of product complaints, breathing circuits are experiencing discolored fluid which are formed when therapy was being given with specific medication through the nebulizer cup. Discoloration is caused by a reaction between medicated mist and an inadvertent/unapproved addition of a nickel coating on the spring component.

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:57 PM UTC

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