Phasitron5 breathing circuits recalled for nickel-coated spring discoloration
Percussionaire Corporation is recalling Phasitron5 breathing circuits (P5-10, P5-HC, P5-UC-10) due to discolored fluid caused by an unintended nickel coating on the spring component reacting with medicated mist. 43,830 devices have been distributed across the U.S.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification indicates serious adverse health consequences are possible. The inadvertent nickel coating on a breathing therapy device poses potential health risks through inhalation exposure during therapy.
Plain-English summary
Percussionaire Corporation is recalling the Phasitron5 breathing circuit (models P5-10, P5-HC, and P5-UC-10), used as a component of Intrapulmonary Percussive Ventilation systems for airway clearance therapy. 43,830 units have been distributed across the United States.
The circuits are experiencing discolored fluid during therapy when specific medications are used through the nebulizer cup. The discoloration results from a chemical reaction between medicated mist and an inadvertent, unapproved nickel coating on the spring component that was not intended to be part of the final product.
The FDA has classified this as a Class I recall due to potential for serious adverse health consequences. Consumers and healthcare providers using affected devices should discontinue use and contact Percussionaire Corporation for return or replacement instructions.
The recalled product
- Product
- Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provide airway clearance therapy
- Manufacturer
- Percussionaire Corporation
- Hazard
- nickel-contamination
- chemical-reaction
Distribution
Distributed in 40 states:
- AL
- AR
- CA
- CO
- CT
- FL
- GA
- ID
- IL
- KS
- KY
- LA
- MA
- MD
- ME
- MI
- MN
- MO
- MT
- NC
- ND
- NE
- NH
- NJ
- NV
- NY
- OH
- OK
- OR
- PA
- RI
- SC
- SD
- TN
- TX
- UT
- VA
- VT
- WI
- WV
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