Z-0031-2026Class I

Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE...

Name: Z-0031-2026 Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE...
Creator: Percussionaire Corporation
Published: 2025-09-17
License: https://open.fda.gov/license/

Percussionaire Corp. / initiated 2025-09-17 / Open, Classified / root cause: design

FDA source

Percussionaire Corporation began a recall of 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... on 2025-09-17. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0031-2026
Classification: Class I
Status: Open, Classified
Initiated: 2025-09-17
Posted: 2025-10-14
Recalling firm: Percussionaire Corp.
Product: 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
Product code: BZO Set, Tubing And Support, Ventilator (W Harness)
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 tag: design
FDA root cause: 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: If 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). Insufficient exhaled tidal volumes may lead to hypoventilation. At 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. At completion of IPV treatment when performed with In-Line Valve: 1) Close pressure relief adjustment valve and turn off IPV device in quick succession. 2) Restore ventilator settings noted before treatment and reassess the patient. 3) Allow the ventilator to complete two or more cycles and adjust settings, if necessary, to ensure exhaled tidal volumes are adequate. Warning: 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. Customers asked to do the following: 1) Print and post updated instructions for use throughout your facility. 2) Communicate and train primary users of IPV therapy. 3) Review instructional protocols and update as needed to conform to the updated instructions. 4) 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. Distributors were asked to forward the notice to their customers. Questions can be directed to firm via email at: [email protected]
Quantity in commerce: 59160
Distribution: Worldwide distribution. US nationwide, Russia, Japan, Switzerland, Canada, Qatar, Chile, South Africa, United Kingdom, Israel, Turkey, and UAE
Product codes and lots: UDI-DI: 00849436000723. Lots: 240326, 250116, 240418, 250324, 240610, 250616, 240620, 241121, 230612, 240826, WO04884, 241118, WO06020, 241203, WO05019, 250111, WO04827, WO04756. Instructions for Use P20020 Rev F

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0031-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0031-2026	Class I	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-14

Product code BZO

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)