FDAFDA · Alimentos y medicamentos·N.º oficial Z-2637-2024
McGRATH" MAC EMS Video Laryngoscope, REF: 300-200-000 , Non-Sterile, Rx Only
Publicado el 28 de agosto de 2024 · Inicio del retiro: 9 de julio de 2024
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Battery management system within Laryngoscope devices may deplete below the deign threshold which may result in thermal event followed by risk of explosion.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Covidien
- Distribuidor
- 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, Azerbaijan, Bahamas, Bahrain, Bangladesh, Barbados, Belgium, Bermuda, Bhutan, Bosnia, Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Cameroon, Canada, Canary Islands, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican, Rep. Dutch Antilles, Egypt, El Salvador, Estonia, Faroe Islands, Fiji, Finland, France, French Guiana, French Polynesia, Germany, Ghana, Greece, Guadeloupe, Guatemala, Guyana, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Islamic, Republic of Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania Luxembourg Macao Malaysia Maldives Malta Martinique Mauritius Mexico Moldova, Republic of Mongolia, Morocco, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, North Macedonia, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion Romania, Russian Federation, Rwanda, Saint Martin, Saint Pierre And Miquelon, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Togo Trinidad And Tobago, Tunisia, Turkey, Turkmenistan, Uganda, Ukraine, United Arab Emirates, United Kingdom, United States, Uruguay, Viet Nam, Virgin Islands, U.S. Wallis And Futuna.
- Lote
- UDI: 15060272980112. All serial Numbers prior to 366170 and Lot/Serial Numbers:373090 366392 366474 372653 372729 372974 373035 373044 373063 373086 373504 373507 377641 377646 377653 377667 377669 377924 378165 378301 378318 378417 378420 378471 382906 383017 383303 383304 383386 383394 383414 383440 383441 383484 383505 383506 383507 383541 383675 383763 383765 390634 390640 390662 390671 390682 390696 390753 390766 395275 395358 395364 395373 395411 395419 395527 395577 395591 395658 395665 395668 395671 395691 395704 395749 395827 395849 395871 395894 395895 395909 395926 396011 396031 396073 396247 396263 401797 401798 401842 401855 401860 401956 401964 402000 402017 402046 402140 402235 402241 402269 402272 373100 373101 373102 373103 373104 373105 373106 373107 373108 373111 373112 373113 373114 373115 373116 373117 373118 373119 373120 373121 373122 373123 373124 373125 373126 373127 373128 373131 373132 373133 373134 373135 373136 373137 373138 373139 373140 373141 373142 373143 373144 373145 373147 373148 373149 373150 373151 373152 373153 373154 373155 373156 373157 373158 373159 373160 373161 373162 373164 373165 373167 373168 373169 373170 373171 373172 373173 373174 373175 373176 373177 373178 373179 373180 373181 373182 373183 373186 373187 373188 373189 373190 373191 373193 373194 373195 373196 373197 373198 373199 373200 373201 373202 373203 373204 373205 373206 373207 373208 373209 373210 373211 373212 373213 373214 373215 373216 373217 373219 373220 373221 373222 373223 373225 373226 373227 373228 373230 373231 373232 373233 373234 373235 373236 373237 373238 373239 373240 373242 373243 373244 373245 373246 373247 373249 373250 373251 373252 373253 373254 373255 373256 373257 373258 373259 373260 373261 373262 373263 373264 373265 373266 373267 373268 373269 373270 373271 373272 373273 373274 373275 373276 373277 373278 373279 373280 373281 373284 373285 373286 373287 373288 373289 373290 373291 373292 373293 366170 366176 366180 366187 366189 366194 366200 366205 366208 366210 366212 366214 366215 366230 366232 366234 366235 366238 366241 366243 366244 366246 366247 366250 366252 366254 366258 366259 366261 366262 366263 366264 366265 366266 366267 366268 366272 366274 366276 366278 366279 366280 366282 366283 366284 366286 366288 366289 366290 366291 366292 366293 366295 366296 366299 366301 366302 366303 366304 366305 366306 366308 366309 366311 366313 366314 366318 366321 366322 366324 366325 366326 366327 366329 366330 366331 366332 366333 366335 366336 366337 366339 366341 366342 366343 366344 366346 366347 366349 366351 366352 366353 366354 366355 366356 366357 366358 366359 366360 366361 366362 366364 366365 366366 366367 366369 366370 366371 366372 366373 366374 366375 366376 366377 366379 366380 366381 366382 366384 366385 366386 366387 366388 366389 366390 366391 366393 366394 366395 366398 366399 366400 366401 366402 366403 366404 366405 366406 366407 366408 366409 366411 366412 366415 366416 366417 366418 366424 366426 366427 366430 366431 366432 366433 366435 366438 366439 366445 366449 366461 366465 366469 366470 366471 366475 366479 366480 366481 366484 366485 366486 366488 366494 366497 366498 366500 366501 366503 366505 372514 372519 372520 372523 372525 372527 372550 372554 372559 372567 372571 372577 372578 372582 372587 372595 372596 372601 372602 372603 372604 372605 372607 372608 372613 372615 372617 372618 372619 372620 372621 372622 372623 372625 372626 372628 372629 372633 372634 372635 372640 372642 372643 372644 372646 372647 372648 372650 372651 372654 372657 372659 372660 372661 372662 372663 372664 372665 372666 372668 372669 372670 372671 372672 372673 372674 372675 372676 372677 372678 372679 372680 372681 372682 372683 372685 372686 372687 372688 372689 372690 372691 372692 372693 372694 372695 372696 372697 372698 372699 372700 372701 372702 372703 372704 372705 372706 372707 372708 372709 372711 372712 372713 372714 372715 372716 372717 372718 372720 372721 372722 372723 3
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
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