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IPV Therapy Device Recall: Percussionaire Removes Certain Phasitron 5 Breathing Circuits Due to Risk of Nickel Exposure

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.

The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. This recall involves removing certain devices from where they are used or sold. This device may cause serious injury or death if you continue to use it.

Questions?

Customers in the U.S. with questions about this recall should contact FSCA@sentec.com.