VDR4 Phasitron Breathing Circuit (Percussionaire) – Venturi Component Stuck (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Percussionaire Corporation
Lot Codes / Batch Numbers
-Phasitron Kit, VDR, Single Patient, Case of 10 Model Number: PRT 992 Lot Code: WO045667 - VDR4 Humidification Kit with Cross Tee
Products Sold
-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
Percussionaire Corporation is recalling VDR4 Phasitron Breathing Circuit Models that contain the venturi component: -A50094 D 5PK, Phasitron due to Due to internal venturi component getting transiently stuck in the forward position within the breathing circuit and may cause a reduction of amplitud. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 12/23/2024, the firm sent an "Urgent Medical Device Notification" to customers informing them that due to recently becoming aware through one customer complaint that the venturi component transiently stopped oscillating while in use. The patient experienced a slight desaturation (low oxygen). When the Phasitron is stuck, the system continues to deliver pressures and volumes, but with reduced amplitude. The set values return when the venturi resumes oscillation. Customers are instructed to: 1. Please review all inventory for impacted lots referenced in the table below. 2. An enhanced Phasitron pre-use check has been developed to evaluate circuits for this issue which replaces the standard pre-use verification until affected products have been replaced at your facility. Please post the instructions provided in Appendix 2 in all areas of your facility. This enhanced pre-use check is to be completed for each new Phasitron breathing circuit in the lots identified below. 3. If product fails the pre-use check found in Appendix 2, DO NOT USE and dispose per your institutional protocol and contact FSCA@sentec.com for product exchange. 4. If a product malfunction is identified during use, please IMMEDIATELY STOP USE of the device and dispose according to your institutional protocol and contact FSCA@sentec.com for product exchange. 5. Complete and Return Acknowledgement form (see Appendix 1) after reviewing and implementing the requested actions by January 31, 2024. 6. After receipt of replacement product: o Dispose remaining product from affected lots per facility protocol. For any question, email FSCA@sentec.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026