FDA Device Recall Z-0960-2025

Percussionaire Corporation · Sandpoint, ID

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death. Distribution is nationwide and the recall remains in progress.

Device

VDR4 Phasitron Breathing Circuit Models that contain the venturi component: -A50094 D 5PK, Phasitron Kit, VDR, Single Patient, 5pk -A51001, VDR4 Control Unit Tester -PRT 991, VDR W/SWIVEL T SINGLE PATIENT PHASITRON -PRT 992, VDR4 HUMIDIFICATION ADAPTER KIT, CASE OF 10 -PRT 993, VDR4 Humidification Kit with Cross Tee, Case of 10 The Phasitron breathing circuit kit is intended to be used for continuous ventilation intended for controlled ventilation of patients

Lot / serial / GTIN: -Phasitron Kit, VDR, Single Patient, 5pk Model Number - A50094-D-5PK UDI-DI code: 00849436000259 Lot Codes: WO04294 WO04424 WO04764 WO05070 WO05186 WO05460 WO05685 WO05910 WO06388 WO06576 WO06883 WO07095 WO07196 WO07317 WO07405 WO07450 WO07696 - Control Unit Tester Model Number: A51001 VDR4 Lot Codes: WO04750 WO06701 - VDR W/Swivel T Single Patient Phasitron Model Number: PRT 991 Lot Code: WO04733 - VDR4 Humidification Adapter Kit, Case of 10 Model Number: PRT 992 Lot Code: WO045667 - VDR4 Humidification Kit with Cross Tee, Case of 10 Model Number: PRT 993 Lot Codes: WO04745 WO04832 WO04893 WO04893 WO05309 WO06523 WO07080 WO07283

Quantity: 4,727 packs/cases

Reason for recall

Due to internal venturi component getting transiently stuck in the forward position within the breathing circuit and may cause a reduction of amplitude and volume of ventilation.

Recall record

Recall number: Z-0960-2025
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Worldwide - U.S. Nationwide distribution in the states of AZ, FL, IL, MS, MO, NE, NJ, NY, NC, RI, TX, UT, and WV. The countries of Belgium, Canada, France, Hong Kong, Netherlands, Russia, Switzerland and Turkey.
Recall initiated: 2024-12-23
Classified by FDA Center: 2025-01-23
FDA published: 2025-01-29
Recalling firm: Percussionaire Corporation
Firm location: Sandpoint, ID

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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