{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "215428", "product_res_number": "Z-0031-2026", "event_date_initiated": "2025-09-17", "event_date_posted": "2025-10-14", "recall_status": "Open, Classified", "res_event_number": "97374", "product_code": "BZO", "product_description": "Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve Sentec Instructions for Use", "code_info": "UDI-DI: 00849436000723.\nLots: 240326, 250116, 240418, 250324, 240610, 250616, 240620, 241121, 230612, 240826, WO04884, 241118, WO06020, 241203, WO05019, 250111, WO04827, WO04756.\n\nInstructions for Use P20020 Rev F", "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": "208-263-2549", "reason_for_recall": "IFU update; in-line valve, with pressure relief seal may leak when used with ventilator; don't use in neonates/infants, with target tidal volumes less-than50mL or less-than10kg- at high risk of cardiopulmonary/neurological compromise due to unrecognized hypoventilation, updates for continued use in others before design update; leak may cause respiratory acidosis, hypoxemia, or respiratory failure.", "root_cause_description": "Device Design", "action": "On 9/17/2025, correction notices were emailed to customers who were informed of future design update and current instructions for use update, and advised:\n\nIf adequate exhaled tidal volumes cannot be achieved with the In-Line Valve in place, consider removing the IN-Line Valve from the circuit when IPV therapy is not being delivered or choose a different treatment configuration (e.g., direct to artificial airway). \n\nInsufficient exhaled tidal volumes may lead to hypoventilation.\n\nAt initial placement of the In-Line Valve in the inspiratory limb: (either at the patient wye or on the dry side of the humidifier) Allow the ventilator to complete two or more cycles and adjust settings, if necessary, to compensate for any potential leaks and to ensure exhaled tidal volumes are adequate.\n\nAt completion of IPV treatment when performed with In-Line Valve:\n1) Close pressure relief adjustment valve and turn off IPV device in quick succession.\n2) Restore ventilator settings noted before treatment and reassess the patient.\n3) Allow the ventilator to complete two or more cycles and adjust settings, if necessary, to ensure exhaled tidal volumes are adequate.\n\nWarning: The In-Line Valve should not be used in neonates and infants who are at high risk of cardiopulmonary or neurological compromise due to unrecognized hypoventilation.\n\nCustomers asked to do the following:\n1) Print and post updated instructions for use throughout your facility.\n2) Communicate and train primary users of IPV therapy.\n3) Review instructional protocols and update as needed to conform to the updated instructions.\n4) Re-label current product by placing the sticker provided by firm on each individual In-Line Valve bag in stock below the current product label.\n\nDistributors were asked to forward the notice to their customers.\n\nQuestions can be directed to firm via email at: FSCA@sentec.com", "product_quantity": "59160", "distribution_pattern": "Worldwide distribution. US nationwide, Russia, Japan, Switzerland, Canada, Qatar, Chile, South Africa, United Kingdom, Israel, Turkey, and UAE", "openfda": { "k_number": [ "K952010", "K893760", "K942569", "K812774", "K841657", "K903404", "K935582", "K813155", "K953785", "K953784", "K833459", "K860879", "K932706", "K903055", "K873900", "K832681", "K952022", "K841722", "K863033", "K823287", "K944531", "K842778", "K860880", "K792030", "K772069", "K932119", "K834570", "K850600", "K792268", "K810341", "K863910", "K823271", "K791761", "K880959", "K942572", "K884525", "K861286", "K860659", "K903083", "K896439", "K791034", "K863756", "K932560", "K873927", "K821064", "K895853", "K890822", "K921510", "K801859", "K841637", "K932563", "K820128", "K841378", "K890011", "K791060", "K812737", "K934753", "K842389", "K801087", "K932712", "K952011", "K791469", "K823479", "K770354", "K834569", "K880637", "K812773", "K830923", "K874559", "K850151", "K820131", "K770581", "K792047", "K813384", "K791856", "K844290", "K830922", 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