Recall Z-2717-2024
Covidien · initiated July 9, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
Codes / lots: Lot Code: 10884521823396 and 10884521776494: Serial Number/Lot Code: 000082 000100 000101 000106 000109 000113 000114 000118 000134 000137 000142 000145 000147 000158 000169 000177 000204 000206 000214 000215 000220 000236 000240 000242 000245 000246 000257 000266 000268 000272 000280 000290 000294 000295 000298 000301 000302 000304 000311 000313 000323 000328 000330 000331 000333 000334 000338 000341 000343 000344 000347 000348 000351 000352 000362 000363 000365 000370 000373 000374 000380 000383 000390 000400 000409 000412 000417 000418 000422 000426 000429 000430 000433 000443 000444 000450 000459 000463 000471 000473 000484 000489 000492 000494 000508 000511 000515 000532 000534 000540 000545 000548 000551 000554 000555 000570 000573 000579 000588 000589 000591 000594 000600 000603 000608 000612 000615 000626 000627 000632 000634 000637 000638 000647 000652 000653 000659 000661 000667 000670 000671 000674 000675 000676 000685 000686 000690 000692 000696 000701 000703 000710 000711 000724 000731 000732 000734 000736 000737 000742 000743 000746 000747 000748 000754 000759 000762 000763 000770 000771 000773 000774 000780 000783 000786 000790 000791 000792 000794 000798 000802…
Reason for recall
IFU update to address device's battery handling information.
FDA-determined cause: Under Investigation by firm
Action taken
On July 17, 2024 Medtronic issued a "Urgent Medical Device Correction" Notice to affected consignees via US Mail and/or E-Mail. Medtronic ask consignee to take the following actions " 1. Follow Important Battery Handling Information stated in the IFU and provided in this notice and maintain a copy of the addendum with the IFU for McGRATH" MAC Video Laryngoscopes. 2. 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. 3. Please complete the enclosed Customer Confirmation Form even if you do not have affected inventory.
Details
- Recall number
- Z-2717-2024
- Initiated
- July 9, 2024
- Posted by FDA
- August 22, 2024
- Product code
- CCW – Laryngoscope, Rigid
- Quantity
- 68,093 devices
- 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, US Virgin Islands and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria…
- Recalling firm
- Covidien, Boulder, CO