Class 1 Device Recall Phasitron5 Breathing Circuit (P510, P5HC, P5UC10)

• Date Initiated by Firm: September 16, 2024
• Date Posted: October 30, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0208-2025
• Recall Event ID: 95436
• 510(K)Number: K905236
• Product Classification: Device, positive pressure breathing, intermittent - Product Code NHJ
• Product: Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provide airway clearance therapy
• Code Information: Model Numbers: P5-10 P5-HC P5-UC-10 UDI-DI codes: Lot Numbers: 240321 240329 240412 240430 240509 240516 240614 240625 240627
• Recalling Firm/ Manufacturer: Percussionaire Corporation; 130 Mcghee Rd Ste 109; Sandpoint ID 83864-8409
• For Additional Information Contact: Robert M. Cormier; 877-425-8746 Ext. 100
• Manufacturer 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.
• FDA Determined 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 FSCA@sentec.com
• 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).
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = NHJ