Summary: Percussionaire is recalling Phasitron 5 breathing circuits due to a nickel coating issue that may aerosolize nickel and pose health risks. Customers are advised to dispose of or return affected products, with specific short-term use guidelines for necessary situations.

Key Takeaways:

  • The recall is due to a nickel coating that could aerosolize, leading to serious health risks like lung injury and allergic reactions.
  • Customers should follow disposal and short-term use guidelines to mitigate risks associated with the affected breathing circuits.

Percussionaire is recalling certain lots of Phasitron 5 breathing circuits due to the unexpected presence of nickel coating on one of the circuit’s components. 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.

Potential Health Risks of Affected Products

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, with no reports of death. The FDA has identified this recall as the most serious type, meaning use of the device may cause serious injury or death.

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On Oct 3, 2024, 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 products 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.

Precautions for Use

Do not:

  • Use to deliver medications.
  • Use for longer than 14 days.
  • Use on patients with an inflammatory state.

About the Phasitron 5 Breathing Circuit

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