FDA Device recall Z-0208-2025
Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provide airway clearance…
- FDA Device
- Class I
- ongoing
- Published 2024-11-06
On 2024-11-06 the FDA classified a Class I recall of Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provide airway clearance… by Percussionaire, citing 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 nebulize….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0208-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-09-16 |
| Published | 2024-11-06 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Percussionaire |
| Distribution | AL, AR, CA, CO, CT, FL, GA, ID, IL, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WI, WV |
Product
Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provide airway clearance therapy
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.
Identifiers
| code_info | Model Numbers: P5-10 P5-HC P5-UC-10 UDI-DI codes: Lot Numbers: 240321 240329 240412 240430 240509 240516 240614 240625 240627 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0208-2025%22
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