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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices

Phasitron Breathing Circuits Recalled for Potential Ventilation Reduction

Agency Publication Date: January 23, 2025
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Summary

Percussionaire Corporation is recalling approximately 4,727 Phasitron Breathing Circuit kits because an internal component can become transiently stuck. If the component gets stuck, it can cause a reduction in the volume of air delivered to a patient during ventilation. Affected models include Phasitron Kit (A50094-D-5PK), Control Unit Tester (A51001), and various Humidification kits (PRT 991, PRT 992, PRT 993). These kits are intended for use in hospitals and healthcare facilities to provide continuous breathing support.

Risk

The internal venturi component may get stuck in the forward position, reducing the amplitude and volume of ventilation. This defect can prevent a patient from receiving adequate oxygen and breathing support, posing a significant risk in critical care settings. No incidents or injuries have been reported to date.

What You Should Do

  1. This recall affects Phasitron Breathing Circuits and kits, including models A50094-D-5PK, A51001, PRT 991, PRT 992, and PRT 993, which are used for continuous patient ventilation.
  2. Check the model and lot numbers printed on the device packaging to determine if your unit is affected. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device. Contact Percussionaire Corporation or your distributor to arrange return, replacement, or correction.
  4. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional questions.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Phasitron Kit, VDR, Single Patient (5pk)
Model / REF:
A50094-D-5PK
Lot Numbers:
WO04294
WO04424
WO04764
WO05070
WO05186
WO05460
WO05685
WO05910
WO06388
WO06576
WO06883
WO07095
WO07196
WO07317
WO07405
WO07450
WO07696
UDI:
00849436000259

Intended for continuous ventilation of patients.

Product: VDR4 Control Unit Tester
Model / REF:
A51001
Lot Numbers:
WO04750
WO06701
Product: VDR W/Swivel T Single Patient Phasitron
Model / REF:
PRT 991
Lot Numbers:
WO04733
Product: VDR4 Humidification Adapter Kit (Case of 10)
Model / REF:
PRT 992
Lot Numbers:
WO045667
Product: VDR4 Humidification Kit with Cross Tee (Case of 10)
Model / REF:
PRT 993
Lot Numbers:
WO04745
WO04832
WO04893
WO05309
WO06523
WO07080
WO07283

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95979
Status: Active
Manufacturer: Percussionaire Corporation
Sold By: Medical device distributors; Hospitals; Healthcare facilities
Manufactured In: United States
Units Affected: 4,727 packs/cases
Distributed To: Arizona, Florida, Illinois, Mississippi, Missouri, Nebraska, New Jersey, New York, North Carolina, Rhode Island, Texas, Utah, West Virginia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท FDA Press Release ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.