Percussionaire Phasitron 5 Circuit Recall Designated Class I

FDA today announced that Percussionaire’s recall of certain Phasitron 5 breathing circuits has been identified as Class I. The device was recalled due to the unexpected presence of nickel which could cause adverse health outcomes.

The Phasitron 5 breathing circuit is part of the Phasitron 5 system which provides intrapulmonary percussive ventilation (IPV) therapy to patients needing mechanical ventilation. The therapy can improve gas exchange and help keep the airways clear during ventilation, according to the company.

On Oct. 3, Percussionaire, which is now a part of Sentec, sent an Urgent Medical Device Recall letter informing users that certain lots of the circuits contained the unexpected presence of a nickel coating on one of the components. The coating’s presence has the potential to react to combinations of saline mixed with albuterol and N-acetylcysteine causing discoloration and may aerosolize the nickel during normal clinical use. This reaction could expose patients to higher than expected levels of nickel, resulting in lung injury from inflammation, severe airway narrowing, lower immunity, allergic reactions, and death. The company reported three injuries, and no deaths related to the issue.

Categorized as a product removal, the company said not to use product from the affected lots, dispose of all opened or used circuits, and return all unopened products. If affected lots must be used because there are not replacement products available, Percussionaire recommends following updated instructions, including to rinse with sterile water after use and allow to air dry, only use saline as the liquid in the nebulization cup, and to stop use if unexpected symptoms occur. Additionally, the recall notice detailed that the product should not be used to deliver medications, be used for longer than 14 days, or on patients with an inflammatory state.

The part numbers/lot numbers included in the recall are: