Covidien: McGrath Mac 2 Laryngoscope Blades Recalled for Blurred or Obscured Screens

Agency Publication Date: November 1, 2023

Summary

Covidien has recalled 84,734 units of McGrath Mac 2 Disposable Laryngoscope Blades because they may have been treated with an ineffective anti-fog agent. This defect can lead to condensation buildup on the camera lens, causing the display screen to become blurred or completely obscured during use. This medical device is primarily used by healthcare professionals to view a patient's airway during intubation procedures. If the screen becomes obscured at a critical moment, it could lead to delayed procedures or airway trauma.

Risk

The ineffective anti-fog coating allows condensation to accumulate on the blade, which can blur or block the medical provider's view of the patient's vocal cords. This visibility failure during an intubation procedure poses a risk of airway injury or delayed medical treatment for patients in respiratory distress.

What You Should Do

Identify if you have the affected products by checking for McGrath Mac 2 Disposable Laryngoscope Blades with Reference Numbers 350-017-000 or 350-084-000.
For Reference Number 350-017-000, check for UDI 10884521816336 and Lot Numbers 22082207 or 22083101.
For Reference Number 350-084-000, check for UDI 10884521824386 and Lot Number 22102001.
Contact your healthcare provider or the manufacturer, Covidien, at their Boulder, Colorado facility for further instructions and information regarding potential refunds or replacements.
For additional questions or to report a problem, 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: McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000

Model / REF:

350-017-000

UPC Codes:

10884521816336

Lot Numbers:

22082207

22083101

Product: McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000

Model / REF:

350-084-000

UPC Codes:

10884521824386

Lot Numbers:

22102001

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92895

Status: Active

Manufacturer: Covidien

Sold By: Authorized medical distributors

Manufactured In: United States

Units Affected: 2 products (42,367)

Distributed To: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, Wyoming

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

Risk

What You Should Do

Identify if you have the affected products by checking for McGrath Mac 2 Disposable Laryngoscope Blades with Reference Numbers 350-017-000 or 350-084-000.

For Reference Number 350-017-000, check for UDI 10884521816336 and Lot Numbers 22082207 or 22083101.

For Reference Number 350-084-000, check for UDI 10884521824386 and Lot Number 22102001.

Contact your healthcare provider or the manufacturer, Covidien, at their Boulder, Colorado facility for further instructions and information regarding potential refunds or replacements.

For additional questions or to report a problem, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.