VDR4 Phasitron Breathing Circuit Models that contain the venturi component: -A50094 D 5PK, Phasitron Kit, VDR, Single Pa

FDA device recall Z-0960-2025 · posted 2025-01-23 · Open, Classified

Recall details

Recalling firm

Percussionaire Corporation

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.

Action taken

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.

Root cause

Process control

Status

Open, Classified

Product code

CBK

Quantity affected

4,727 packs/cases

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

Date initiated

2024-12-23

Date posted

2025-01-23

Location

Sandpoint, ID

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