Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10).… recallZ-0208-2025 · Percussionaire Corporation · initiated Sep 16, 2024
Class I Open, Classified All recalls posted in October 2024
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Percussionaire Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Process control
What the company is doing
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 (see Appendix 1) after reviewing and implementing the requested actions below by October 18, 2024. " Return all impacted products " Until unaffected or replacement product is available, affected devices should not be used under the following conditions (Appendix 3): o For the delivery of medications o For use longer than 14 days when using normal saline o On patients with an inflammatory state or with a known nickel allergy o Immediately stop usage if any unexpected symptoms are encountered " Additionally, it is recommend to rinsing the Phasitron 5 after each use with sterile water and allowing it to air dry per the IFU. Percussionaire will: Replace the affected product and exchange with new, unaffected product. Until replacement or unaffected product is available, Customers have been advised to use the product only with saline and only under restricted conditions For questions/assistance - email [email protected]
Recall details
- Recall number
- Z-0208-2025
- Recall class
- Class I (most serious)
- Status
- Open, Classified
- Initiated by the company
- Sep 16, 2024
- Posted by the FDA
- Oct 30, 2024
- Recalling firm
- Percussionaire Corporation
- Quantity
- 43,830 devices
- Product code
- NHJ
- FDA submissions
- K905236
- 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) control, were quarantined, and did not leave the warehouse).
Product description
Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provide airway clearance therapy
Code information (models, lots, serial numbers)
Model Numbers: P5-10 P5-HC P5-UC-10 UDI-DI codes: Lot Numbers: 240321 240329 240412 240430 240509 240516 240614 240625 240627
Other devices under the same FDA submission
14 devices cleared under K905236 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Percussionaire P5Percussionaire Corporation · Device, Positive Pressure Breathing, Intermittent4 recalls2 reports
- Percussionaire F00001-CPercussionaire Corporation · Device, Positive Pressure Breathing, Intermittent2 recalls3 reports
- Percussionaire F00001-C-FRPercussionaire Corporation · Device, Positive Pressure Breathing, Intermittent2 recalls0 reports
- Percussionaire F00001-CPercussionaire Corporation · Device, Positive Pressure Breathing, Intermittent2 recalls0 reports
- Percussionaire F00001-CPercussionaire Corporation · Device, Positive Pressure Breathing, Intermittent2 recalls0 reports
- Percussionaire F00001-C-FRPercussionaire Corporation · Device, Positive Pressure Breathing, Intermittent2 recalls0 reports
- Percussionaire F00012Percussionaire Corporation · Device, Positive Pressure Breathing, Intermittent1 recall3 reports
- Percussionaire Travel AirPercussionaire Corporation · Device, Positive Pressure Breathing, Intermittent1 recall0 reports
- Percussionaire F00012-HTPercussionaire Corporation · Device, Positive Pressure Breathing, Intermittent1 recall0 reports
- Percussionaire P5-HCPercussionaire Corporation · Device, Positive Pressure Breathing, Intermittent1 recall0 reports
- Percussionaire IPV1Percussionaire Corporation · Device, Positive Pressure Breathing, Intermittent1 recall0 reports
- Percussionaire P5Percussionaire Corporation · Device, Positive Pressure Breathing, Intermittent1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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