Reported Jan 29, 2025 · Ongoing
VDR4 Phasitron Breathing Circuit Models that contain the venturi component: -A50094 D 5PK, Phasitron Kit, VDR, Single…
Percussionaire Corporation
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Percussionaire Corporation · 130 Mcghee Rd Ste 109 · Sandpoint, ID · 83864-8409
Is this the product you have?
- 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 codes and dates
10 of 10 products
Products covered by this recall Model / number Barcodes Product as published — 00849436000259Model 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 A51001VDR4 — 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 - Amount recalled
- 4,727 packs/cases
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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