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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/Home Healthcare

Percussionaire Corporation: Distal Phasitron Breathing Circuit Recalled for Assembly Error

Agency Publication Date: January 17, 2024
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Summary

Percussionaire Corporation is recalling 195 units of the Distal Phasitron (Part: S20020), which is used with the VDR-4 control unit for respiratory therapy. The breathing circuit's reservoir bag may have been assembled at the wrong attachment point during manufacturing. If the device is used with this assembly error, it will result in the patient receiving less than optimal respiratory therapy. Consumers should check their devices immediately to see if they match the affected lot numbers and expiration dates.

Risk

An incorrectly attached reservoir bag prevents the breathing circuit from functioning as intended, which can lead to inadequate ventilation or poor delivery of prescribed respiratory therapy to the patient.

What You Should Do

  1. Identify if you have the affected Distal Phasitron (Part: S20020) by checking the packaging for UDI-DI 00849436000693.
  2. Check your device for the specific lot numbers and expiration dates: Lot WO03739 with an expiration of September 13, 2024, or Lot WO04218 with an expiration of November 14, 2024.
  3. If your product matches the affected lots, contact your healthcare provider or Percussionaire Corporation at 130 Mcghee Rd Ste 109, Sandpoint, Idaho, 83864-8409 for further instructions regarding the device and a potential refund.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls if you have additional questions or need to report a problem.

Your Remedy Options

๐Ÿ“‹Other Action

Contact healthcare provider or manufacturer

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Distal Phasitron (Part: S20020), for use with Percussionaire VDR-4 control driver
Model / REF:
S20020
Z-0693-2024
UPC Codes:
00849436000693
Lot Numbers:
WO03739 (Exp September 13, 2024)
WO04218 (Exp November 14, 2024)
Date Ranges: September 13, 2024, November 14, 2024

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93648
Status: Active
Manufacturer: Percussionaire Corporation
Sold By: Percussionaire Corporation
Manufactured In: United States
Units Affected: 195
Distributed To: Rhode Island, California, Texas
Agency Last Updated: January 29, 2024

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 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.