{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
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  },
  "results": [
    {
      "cfres_id": "210266",
      "product_res_number": "Z-0208-2025",
      "event_date_initiated": "2024-09-16",
      "event_date_posted": "2024-10-30",
      "recall_status": "Open, Classified",
      "res_event_number": "95436",
      "product_code": "NHJ",
      "k_numbers": [
        "K905236"
      ],
      "product_description": "Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provide airway clearance therapy",
      "code_info": "Model Numbers:\nP5-10\nP5-HC\nP5-UC-10\nUDI-DI codes:\n\nLot Numbers:\n240321\n240329\n240412\n240430\n240509\n240516\n240614\n240625\n240627",
      "firm_fei_number": "1000524541",
      "recalling_firm": "Percussionaire Corporation",
      "address_1": "130 Mcghee Rd Ste 109 130 Mcghee Rd",
      "address_2": "Ste 109",
      "city": "Sandpoint",
      "state": "ID",
      "postal_code": "83864-8409",
      "additional_info_contact": "Robert M. Cormier\n877-425-8746 Ext. 100",
      "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_description": "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.\n\nCustomer are instructed to:\n\"\tComplete and Return Acknowledgement form (see Appendix 1) after reviewing and implementing the requested actions below by October 18, 2024.\n\"\tReturn all impacted products\n\"\tUntil unaffected or replacement product is available, affected devices should not be used under the following conditions (Appendix 3):\no\tFor the delivery of medications\no\tFor use longer than 14 days when using normal saline\no\tOn patients with an inflammatory state or with a known nickel allergy\no\tImmediately stop usage if any unexpected symptoms are encountered\n\"\tAdditionally, it is recommend to rinsing the Phasitron 5 after each use with sterile water and allowing it to air dry per the IFU.\n\nPercussionaire will:\nReplace the affected product and exchange with new, unaffected product.\nUntil replacement or unaffected product is available, Customers have been advised to use the product only with saline and only under restricted conditions\n\nFor questions/assistance - email FSCA@sentec.com",
      "product_quantity": "43,830 devices",
      "distribution_pattern": "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, \n\nO.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).",
      "openfda": {
        "k_number": [
          "K895485",
          "K140598",
          "K231728",
          "K213564",
          "K072292",
          "K905236",
          "K242438",
          "K981726",
          "K002598",
          "K124032",
          "K113549",
          "K120277",
          "K191912",
          "K132988",
          "K924174",
          "K200988",
          "K151689",
          "K982016",
          "K051964",
          "K781232",
          "K192143",
          "K003684",
          "K140605",
          "K253001",
          "K121955"
        ],
        "device_name": "Device, Positive Pressure Breathing, Intermittent",
        "medical_specialty_description": "Anesthesiology",
        "regulation_number": "868.5905",
        "device_class": "2",
        "registration_number": [
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}