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
240321240329240412240430240509240516240614240625240627
- 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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