Recall Z-2636-2024
Covidien · initiated July 9, 2024
Class I – dangerous or defective products that could cause serious health problems or death
Product
McGrath Mac Video Laryngoscope, REF: 300-000-000 , Non-Sterile, Rx Only
Codes / lots: UDI: 15060272980020 05060272980023 F0602729800201/ All serial Numbers prior to 366170 and Lot/serial number: 370723 370727 370729 370733 370756 370757 370759 370760 370762 370763 370764 370766 370767 370768 370769 370770 370772 370773 370774 370775 370776 370777 370778 370779 370842 370898 370900 370901 370902 370904 370905 370907 370908 370911 370913 370917 370938 370939 370940 370941 370966 370967 370984 370985 370988 370992 371000 371002 371012 371016 371018 371037 371064 371065 371066 371067 371068 371069 371070 371071 371072 371074 371076 371109 371113 371114 371115 371116 371117 371118 371119 371121 371122 371123 371124 371125 371126 371127 371128 371130 371131 371132 371135 371136 371138 371139 371140 371141 371142 371144 371145 371146 371172 371173 371175 371176 371177 371180 371181 371182 371183 371184 371185 371186 371188 371189 371190 371192 371193 371194 371195 371230 371232 371234 371235 371236 371242 371244 371245 371247 371248 371249 371252 371253 371254 371255 371259 371262 371265 371266 371267 371269 371270 371273 371276 371277 371278 371279 371281 371282 371283 371285 371289 371290 371291 371293 371295 371297 371298 371302 371303 371307 371308 371309 371358…
Reason for recall
Battery management system within Laryngoscope devices may deplete below the deign threshold which may result in thermal event followed by risk of explosion.
FDA-determined cause: Device Design
Action taken
On July 17, 2024, Medtronic issued a "Urgent Medical Device Removal and Correction" notification to affected consignees via Mail and/or E-Mail. Medtronic ask consignees to take the following actions: Immediately discontinue use of the devices being removed (300-000-000 and 300-200-000). 1. Uninstall and dispose of the battery assembly from the devices being removed. 2. Return the removed device (300-000-000 and 300-200-000) to Medtronic. 3. Pass this notice on to all who need to be aware within your organization or to any organization where the potentially affected product with the specified serial numbers have been transferred or distributed. 4. Please complete the enclosed Customer Confirmation Form even if you do not have affected inventory. On 9/11/24, updated removal notices were mailed or emailed to customers expanding the recall to include affected video laryngoscopes shipped prior to 2019 that are now past their 5-year useful life and the batteries should be removed, devices should be removed from service and disposed of. The other actions above are the same.
Details
- Recall number
- Z-2636-2024
- Initiated
- July 9, 2024
- Posted by FDA
- August 21, 2024
- Product code
- CCW – Laryngoscope, Rigid
- Quantity
- 75,544 units
- Distribution
- Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico, Virgin Islands and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria…
- Recalling firm
- Covidien, Boulder, CO
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2637-2024 Class I | McGRATH" MAC EMS Video Laryngoscope, REF: 300-200-000 , Non-Sterile, Rx OnlyBattery management system within Laryngoscope devices may deplete below the deign threshold which may result… | 07/09/2024Open, Classified |