Covidien: McGRATH" MAC EMS Video Laryngoscope, REF: 300-200-000 , Non-Sterile, Rx Only

Hazard

Battery management system within Laryngoscope devices may deplete below the deign threshold which may result in thermal event followed by risk of explosion.

Details from the source

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. 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, Azerbaijan, Quantity: 10,449 units Lot/code info: 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

UPC codes

15060272980112

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.