Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provide airway clearance therapy
- Company
- Percussionaire Corporation
- Recall Initiated
- September 16, 2024
- Posted
- October 30, 2024
- Recall Number
- Z-0208-2025
- Quantity
- 43,830 devices
- Firm Location
- Sandpoint, ID
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.
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).
Lot / 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
Root Cause
Process control
Action Taken
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