The FDA has issued a Class I recall for certain lots of Percussionaire’s Phasitron 5 breathing circuits due to the presence of a nickel coating that may aerosolize and pose serious health risks.

RT’s Three Key Takeaways:

  1. Class I Recall Issued: The FDA classified the recall of specific Phasitron 5 breathing circuits as Class I, indicating potential severe health risks, including lung injury, allergic reactions, bronchospasm, and death.
  2. Nickel Coating Hazard: The presence of unexpected nickel coating on a circuit component may aerosolize with saline and certain medications, exposing patients to high nickel levels.
  3. Usage Guidelines Provided: Percussionaire advises disposing of affected products or following strict use instructions, including only using saline in the nebulization cup and limiting use to short-term applications.

Percussionaire is removing certain lots of Phasitron 5 breathing circuits due to the unexpected presence of nickel coating on one of the circuit’s components, according to a medical device recall notice from the US Food and Drug Administration (FDA). 

The nickel coating may react to combinations of saline mixed with albuterol and/or N-acetylcysteine causing both discoloration and the potential to aerosolize the nickel during normal clinical use, which may expose patients to higher-than-expected levels of nickel.

The FDA has identified this recall as a Class I recall, the most serious type. The use of affected products may cause serious adverse health consequences, including lung injury from inflammation, severe airway narrowing (bronchospasm), lower immunity (humoral immunity), allergic reactions, and death. There have been three reported injuries. There have been no reports of death.

The intrapulmonary percussive ventilation (IPV) Phasitron 5 breathing circuit is part of the Phasitron 5 system that provides IPV therapy to patients who are receiving mechanical ventilation to help them breathe. This type of therapy can improve gas exchange and help keep the airways clear during ventilation.

Affected Product:

  • Product Names: Phasitron 5 breathing circuits 
  • Part Numbers/Lot Numbers:
    • P5-10/240329, 240412,240430, 240509, 240516, 240614, 240625 
    • P5-HC-5/240321
    • P5-UC-10/240627

What to Do:

On Oct 3, Percussionaire sent all affected customers an Urgent Medical Device Recall letter recommending the following actions: 

  • Dispose of all opened or used affected products. 
  • Return all unopened, impacted products. 
  • If short-term use of affected product is required, follow the instructions provided by the firm, which include:
    • Rinsing with sterile water after use and air dry.
    • Only using saline in the nebulization cup.
    • Stopping use if unexpected symptoms occur.
    • Do not:
      • Use to deliver medications
      • Use for longer than 14 days
      • Use on patients with an inflammatory state

Customers in the US with questions about this recall should contact [email protected].