Z-0208-2025Class I

Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation...

Name: Z-0208-2025 Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation...
Creator: Percussionaire Corporation
Published: 2024-09-16
License: https://open.fda.gov/license/

Percussionaire Corp. / initiated 2024-09-16 / Open, Classified / root cause: manufacturing process

FDA source

Percussionaire Corporation began a recall of Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provide airway clearance therapy on 2024-09-16. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0208-2025
Classification: Class I
Status: Open, Classified
Initiated: 2024-09-16
Posted: 2024-10-30
Recalling firm: Percussionaire Corp.
Product: Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provide airway clearance therapy
Product code: NHJ Device, Positive Pressure Breathing, Intermittent
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.
Root cause tag: manufacturing process
FDA 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 (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]
Quantity in commerce: 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) control, were quarantined, and did not leave the warehouse).
Product codes and lots: Model Numbers: P5-10 P5-HC P5-UC-10 UDI-DI codes: Lot Numbers: 240321 240329 240412 240430 240509 240516 240614 240625 240627

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0208-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0208-2025	Class I	Ongoing	Voluntary: Firm initiated	2024-11-06	2024-10-30

Product code NHJ

K905236Class IIIpv Percussionator Family & Related AccessoriesPercussionaire Corp. / cleared 1991-04-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)