Getinge Usa Sales Inc: Sevoflurane Vaporizers Recalled for Potential Hydrogen Fluoride Exposure

Agency Publication Date: May 31, 2024

Summary

Getinge is recalling approximately 120 Sevoflurane Maquet Filling vaporizers used with Flow-i (C20, C30, C40), Flow-c, and Flow-e anesthesia systems. The anesthesia medication (sevoflurane) used with these devices can break down into hydrogen fluoride, which is a toxic substance. This chemical degradation can lead to severe health issues for both patients and healthcare providers who may inhale it or come into contact with it on their skin. Consumers should contact their healthcare provider or the manufacturer immediately regarding this critical safety issue.

Risk

The anesthetic gas can degrade into hydrogen fluoride, which can cause severe respiratory tract irritation, lung fluid buildup (edema), skin blistering, and life-threatening chemical imbalances like severe hypocalcemia and hypomagnesemia.

What You Should Do

Identify if your facility uses the Vaporizer Sevoflurane Maquet Filling (Component of Flow-i C20, C30, C40, Flow-c, or Flow-e) by checking the product code/REF number 6682282.
Check the serial number on your device to see if it falls within the affected range of 17003 through 23454.
Verify the Unique Device Identifier (UDI/DI) on the product labeling, which is 07325710000212.
Immediately contact your healthcare provider or the manufacturer, Getinge USA Sales Inc., to discuss necessary safety precautions and the next steps for your specific equipment.
Monitor any patients or staff who may have been exposed for signs of respiratory irritation, skin ulceration, or chemical burns.
For further information or to report additional concerns, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

manufacturer or healthcare provider Consultation

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

Affected Products

Product: Vaporizer Sevoflurane Maquet Filling (Component of: Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e)

Model / REF:

6682282

UPC Codes:

07325710000212

Lot Numbers:

Serial Numbers: 17003 - 23454

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94502

Status: Active

Manufacturer: Getinge Usa Sales Inc

Sold By: Getinge Usa Sales Inc

Manufactured In: United States

Units Affected: 120 units (US)

Distributed To: California, Colorado, Indiana, Missouri, Oregon, Virginia, Washington

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 if your facility uses the Vaporizer Sevoflurane Maquet Filling (Component of Flow-i C20, C30, C40, Flow-c, or Flow-e) by checking the product code/REF number 6682282.

Check the serial number on your device to see if it falls within the affected range of 17003 through 23454.

Verify the Unique Device Identifier (UDI/DI) on the product labeling, which is 07325710000212.

Immediately contact your healthcare provider or the manufacturer, Getinge USA Sales Inc., to discuss necessary safety precautions and the next steps for your specific equipment.

Monitor any patients or staff who may have been exposed for signs of respiratory irritation, skin ulceration, or chemical burns.

For further information or to report additional concerns, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.