McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only

FDA device recall Z-0169-2024 · posted 2023-11-01 · Open, Classified

Recall details

Recalling firm

Covidien

Reason for recall

Laryngoscope blades may contain an ineffective application of anti-fog agent which may result in condensation accumulating causing the screen to be blurred or obscured.

Action taken

On August 10, 2023 Medtronic ( Parent company of Covidien) issued an Urgent via UPS. Medtronic ask consignees to take the following actions: 1. Quarantine all unused product from the affected lots of McGRATH MAC 2 disposable laryngoscope blades. See attachment A for guidance on identifying potentially affected devices. 2. Return all unused product from the affected lots in your inventory to Medtronic as described on the Customer Confirmation Form. 3. Please complete and return the enclosed Customer Confirmation Form even if you do not have unused inventory. 4. Pass on this notice to all those who need to be aware within your organization or to any organization where the potentially affected product from the specified lots has been transferred or distributed. 5. Adverse reactions or quality problems experienced with this product should be reported to FDA and Medtronic: . Online at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm (form available to fax or mail), or . Call FDA (800) FDA-1088 . Call Medtronic Quality Assurance at 800-255-6774 option 1, then option 1

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

CCW

Quantity affected

42,367

Distribution

US: AK AL AR AZ CA CO CT DE FL GA IA IL IN KS LA MA MD MI MO MT NC ND NH NJ NM NY OH OK OR PA SD TN TX UT VA WA WI WY OUS: Australia Austria Azerbaijan Bahamas Belgium Croatia Czech Republic Denmark F

Date initiated

2023-08-10

Date posted

2023-11-01

Location

Boulder, CO