FDAClass IJanuary 29, 2025

VDR4 Phasitron Breathing Circuit recall

VDR4 Phasitron Breathing Circuit Models that contain the venturi component: -A50094 D 5PK, Phasitron Kit, VDR, Single Patient, 5pk -A51001, VDR4…

Why was VDR4 Phasitron Breathing Circuit recalled?

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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

-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

Product
VDR4 Phasitron Breathing Circuit Models that contain the venturi component: -A50094 D 5PK, Phasitron Kit, VDR, Single Patient, 5pk -A51001, VDR4…
Recalling firm
Percussionaire Corporation
Quantity
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 and Turkey.
Recall date
January 29, 2025
Classification
Class I
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls