Percussionaire Corporation recalls Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to prov…

Recall date

September 16, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0208-2025

FDA classification

Class I

Brand / firm

Percussionaire Corporation

Sold / distributed

U.S.: PA, AR, MI, CA, TX, OH, NY, FL, IL, NE, OR, GA, WI, MO, OK, AL, WV, MT, CO, LA, VA, CT, SC, NH, NV, NC, NJ, MI, UT, ID, ME, MN, SD, ID, ND, KS, KY, TN, MD, VT, MA, RI, O.U.S.: Canada, Switzerland (all products shipped OUS remained in Sentec AG's (distributor, parent company of Percussionaire)…

Why it was recalled

As a result of product complaints, breathing circuits are experiencing discolored fluid which are formed when therapy was being given with specific medication through the nebulizer cup. Discoloration is caused by a reaction between medicated mist and an inadvertent/unapproved addition of a nickel coating on the spring component.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provide airway clearance therapy