Smiths Medical ASD Inc.: Pneupac paraPAC plus Ventilators Recalled for Incorrect Tidal Volume Settings

Agency Publication Date: September 11, 2024

Summary

Smiths Medical ASD Inc. is recalling 12,438 Pneupac paraPAC plus 300 and 310 ventilator kits because the tidal volume control knob can move unexpectedly from its original position. This defect occurs when the device is set to high (1000-1500 mL) or low (70-150 mL) tidal volume settings, which can lead to a patient receiving too much or too little air. The recall affects all serial numbers for models REF P300NXX and REF P310NXX distributed worldwide.

Risk

The control knob may shift on its own during use, causing the ventilator to deliver a different volume of air than intended by the healthcare provider. This can result in respiratory complications, lung injury, or insufficient oxygen delivery to the patient.

What You Should Do

Identify your device by checking the model number on the ventilator kit; affected models include Pneupac paraPAC plus 300 (REF P300NXX) and Pneupac paraPAC plus 310 (REF P310NXX).
Verify if your unit is part of the recall by checking the serial number; all serial numbers for these two specific models are included in this action.
Closely monitor the tidal volume settings during use, especially when set to the high range (1000-1500 mL) or the low range (70-150 mL), to ensure the knob has not moved from the intended setting.
Contact your healthcare provider or Smiths Medical ASD Inc. immediately for instructions on how to proceed and to receive information regarding any necessary corrective actions or updates for your device.
For further information or to report any adverse events, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer Notification

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

Affected Products

Product: Pneupac paraPAC plus 300 ventilator kit

Model / REF:

REF P300NXX

Z-2973-2024

Lot Numbers:

All Serial Numbers

Product: Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP

Model / REF:

REF P310NXX

Z-2974-2024

Lot Numbers:

All serial numbers

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95025

Status: Active

Manufacturer: Smiths Medical ASD Inc.

Sold By: Smiths Medical ASD Inc.

Manufactured In: United States

Units Affected: 2 products (2198 units; 10,240 units)

Distributed To: Nationwide

Agency Last Updated: October 9, 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 · 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.

Summary

What You Should Do

Identify your device by checking the model number on the ventilator kit; affected models include Pneupac paraPAC plus 300 (REF P300NXX) and Pneupac paraPAC plus 310 (REF P310NXX).

Verify if your unit is part of the recall by checking the serial number; all serial numbers for these two specific models are included in this action.

Closely monitor the tidal volume settings during use, especially when set to the high range (1000-1500 mL) or the low range (70-150 mL), to ensure the knob has not moved from the intended setting.

Contact your healthcare provider or Smiths Medical ASD Inc. immediately for instructions on how to proceed and to receive information regarding any necessary corrective actions or updates for your device.

For further information or to report any adverse events, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.