Public recall detail

McGRATH™ Mac 2 Laryngoscope Blade

2024-01-18

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Recall Safety notice
Quick summary

Quick summary: McGRATH™ Mac 2 Laryngoscope Blade. Date: 2024-01-18.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: McGRATH™ Mac 2 Laryngoscope Blade. Date: 2024-01-18.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandCOVIDIEN LLC
ProductMcGRATH™ Mac 2 Laryngoscope Blade
IssueMedical devices - Performance
Recall classType II
IdentificationRA-74924

Affected products

ProductMcGRATH™ Mac 2 Laryngoscope Blade
Lot22102001 22082207 22083101
Model350-017-000 350-084-000
Serial number22102001 22082207 22083101
DescriptionMcGRATH™ Mac 2 Laryngoscope Blade

Issue

Medtronic received six (6) complaints of poor picture quality and foggy and/or blurred images on the McGRATH™ Mac 2 video laryngoscope screen during use of these blades. The reports indicated a delay to treatment while an alternate device was located and/or oral tissue injury due to multiple intubation attempts. Medtronic investigation of these customer reports identified a manufacturing issue which resulted in an ineffective application of the antifog agent on the blades. An ineffective application of the anti-fog coating can result in condensation accumulating on the blade during use, resulting in the image on the video laryngoscope screen being blurred or obscured. Recall start date: August 8, 2023

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Anaesthesiology
CompaniesCovidien LLC 15 Hampshire Street, Mansfield, Massachusetts, United States, 02048
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-74924
Background{}
CompaniesCovidien LLC 15 Hampshire Street, Mansfield, Massachusetts, United States, 02048
AudiencesHealthcare
Source updated2024-01-18

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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