Recall Z-0208-2025— Percussionaire Corporation
Class I · Ongoing
Class I FDA medical device recall by Percussionaire Corporation, initiated 2024-09-16. It names one FDA 510(k) clearance: K905236. 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..
- Recalling firm
- Percussionaire Corporation
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2024-09-16
- Firm location
- Sandpoint, ID, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provide airway clearance therapy
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.