McGRATH MAC recallZ-0169-2024 · Covidien · initiated Aug 10, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Covidien or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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
Recall details
- Recall number
- Z-0169-2024
- Status
- Open, Classified
- Initiated by the company
- Aug 10, 2023
- Posted by the FDA
- Nov 1, 2023
- Recalling firm
- Covidien
- Quantity
- 42,367
- Product code
- CCW
- 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 Finland France French Guiana Germany Guadeloupe Hong Kong Hungary Ireland Israel Italy Kazakhstan Korea, Republic Of Malta Mayotte Netherlands New Zealand Norway Pakistan Poland Portugal Reunion Romania Spain Sweden Switzerland Turkmenistan United Arab Emirates
Product description
McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only
Code information (models, lots, serial numbers)
UDI: 10884521824386/ Lot # 22102001
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- McGRATH MAC 350-084-000Covidien LP · LARYNGOSCOPE, RIGID1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 92895).
- Z-0168-2024 · Open, ClassifiedMcGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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