Recall Z-0208-2025 ยท NHJ Device, Positive Pressure Breathing, Intermittent
Percussionaire Corporation
Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provide airway clearance therapy
| Date | Oct 30, 2024 (initiated Sep 16, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process control |
| Action | On 10/03/2024, the firm emailed "Urgent Medical Device Recall" Letter informing customer that Percussionaire became aware of discoloration of fluid collecting in the Phasitron breathing circuit after extended Intrapulmonary Percussive Ventilation (IPV) therapy. I was determined that there is a reaction within the nebulizer cup between the combinations of saline mixed with albuterol and/or N-acetylcysteine, and an inadvertent nickel-coating on the spring. The reaction can aerosolize the nickel under normal clinical use. Customer are instructed to: " Complete and Return Acknowledgement form ( |
| Quantity | 43,830 devices |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K905236 | IPV PERCUSSIONATOR FAMILY & RELATED ACCESSORIES Percussionaire Corp., Apr 18, 1991 |