Device Recall Giraffe Infant Warmers

  • Model / Serial
    Serial Numbers: HDJR52093 HDJQ52878 HDJS51010 HDJP51983 HDJN52273 HDJN52274 HDJN52275 HDJN52276 HDJP50604 HDJP50605 HDJM50388 HDJR56613 HDJQ52689 HDJR50734 HDJR50735 HDJS50028 HDJP52371 HDJP52558 HDJN51693 HDJN51694 HDJR56618 HDJQ51960 HDJS52390 HDJM50693 HDJM51714 HDJM51716 HDJM51717 HDJM51718 HDJM52096 HDJN52193 HDJN52194 HDJN52195 HDJN52196 HDJN52197 HDJP52562 HDJP52563 HDJP52564 HDJP52565 HDJQ52920 HDJQ52917 HDJQ52918 HDJQ52919 HDJQ52921 HDJQ52922 HDJQ52923 HDJQ52924 HDJQ52925 HDJQ52926 HDJQ52927 HDJQ53075 HDJR56481 HDJR56482 HDJR56486 HDJR56487 HDJR56488 HDJR56489 HDJR56490 HDJR56491 HDJR56358 HDJP50531 HDJP50532 HDJR56107 HDJR56370 HDJR56669 HDJR56746 HDJR56747 HDJR56748 HDJM51930 HDJM52089 HDJM51405 HDJM51470 HDJM51471 HDJM51472 HDJM51475 HDJM51847 HDJS51291 HDJS51292 HDJR54229 HDJQ51474 HDJQ51475 HDJQ51476 HDJM52059 HDJM50272 HDJP50634 HDJQ51827 HDJR50477 HDJR57730 HDJM50483 HDJQ52812 HDJS52096 HDJR57172 HDJM50694 HDJN51776 HDJN51777 HDJN51778 HDJQ51257 HDJR56005 HDJR56006 HDJR56007 HDJR56008 HDJQ52597 HDJQ52598 HDJQ52599 HDJQ52600 HDJQ52601 HDJN50850 HDJM50704 HDJM50705 HDJM50706 HDJM50707 HDJM50708 HDJM50709 HDJQ53073 HDJR57718 HDJP50352 HDJM50012 HDJP51078 HDJP51079 HDJP51080 HDJQ51561 HDJQ51562 HDJQ51563 HDJR56749 HDJR56750 HDJR56751 HDJR56752 HDJR56753 HDJS50790 HDJS50791 HDJS50792 HDJR57719 HDJR57720 HDJR57721 HDJQ50915 HDJQ50916 HDJQ50917 HDJQ50918 HDJQ50919 HDJS51692 HDJS51693 HDJM51900 HDJM52091 HDJM52092 HDJM52093 HDJS50046 HDJS50047 HDJS50048 HDJR50230 HDJR50231 HDJS50297 HDJP51783 HDJP51784 HDJP51792 HDJP51793 HDJP51796 HDJQ52082 HDJS50733 HDJS50734 HDJS50735 HDJP52863 HDJR50596 HDJR50597 HDJR50598 HDJN50595 HDJM50200 HDJM50201 HDJP52156 HDJP52071 HDJP52072 HDJQ52813 HDJQ52814 HDJQ52815 HDJQ52895 HDJS51414 HDJS51415 HDJS51417 HDJM51320 HDJM51321 HDJM51883 HDJN50762 HDJN50763 HDJN51327 HDJS50042 HDJS50043 HDJR50133 HDJR50134 HDJR50135 HDJR50136 HDJR50138 HDJR50139 HDJR50140 HDJR50141 HDJR50142 HDJR50144 HDJR50145 HDJR50146 HDJR50147 HDJR50148 HDJR50149 HDJR50150 HDJR50151 HDJR50152 HDJR50153 HDJR50154 HDJR50155 HDJR50156 HDJR50158 HDJR50159 HDJR50161 HDJR50143 HDJR50157 HDJR50160 HDJR50299 HDJL50161 HDJL50162 HDJL50163 HDJL50164 HDJL50165 HDJR50298 HDJS51009 HDJP50561 HDJP50562 HDJP50563 HDJP50564 HDJP50565 HDJP50566 HDJQ52690 HDJS50002 HDJS50003 HDJS50004 HDJS50005 HDJS50006 HDJS50007 HDJL50357 HDJL50358 HDJL50360 HDJL50362 HDJL50359 HDJL50383 HDJR52099 HDJR56206 HDJN51948 HDJN51949 HDJN52121 HDJN52122 HDJP52630 HDJP51794 HDJP51795 HDJP52794 HDJP52795 HDJN52437 HDJN52438 HDJN52439 HDJS52720 HDJS52721 HDJR54274 HDJR54275 HDJR52095 HDJR54268 HDJR54269 HDJR54270 HDJR54271 HDJR54272 HDJM50005 HDJM50006 HDJM50007 HDJS51006 HDJS51002 HDJS51003 HDJS51004 HDJS51005 HDJN52376 HDJP50730 HDJR56133 HDJM51307 HDJS51426 HDJS51427 HDJS51458 HDJP51526 HDJP51527 HDJP51528 HDJP52796 HDJP52797 HDJP52798 HDJR56368 HDJR57717 HDJR56207 HDJL50432 HDJL50433 HDJL50434 HDJL50435 HDJQ51484 HDJQ51485 HDJQ51486 HDJQ51487 HDJQ51488 HDJQ51489 HDJQ51490 HDJM51308 HDJP50177 HDJR56361 HDJP51389 HDJP51390 HDJP51391 HDJN50262 HDJN50263 HDJN50264 HDJN50265 HDJP52079 HDJP52080 HDJP52081 HDJP52082 HDJN50541 HDJN50542 HDJN50543 HDJN50544 HDJN50545 HDJN50546 HDJN50547 HDJN50298 HDJN50299 HDJR54214 HDJR54215 HDJR54216 HDJQ50580 HDJQ50581 HDJQ50582 HDJQ50583 HDJQ50584 HDJQ50585 HDJM50056 HDJM50178 HDJM50583 HDJM51924 HDJM52339 HDJM50651 HDJR52092 HDJR52098 HDJM50058 HDJM50097 HDJN51392 HDJR58028 HDJR58029 HDJR58030 HDJR58031 HDJM50142 HDJQ50388 HDJQ50389 HDJQ53023 HDJQ53024 HDJQ53025 HDJQ53026 HDJQ53027 HDJQ53028 HDJQ53029 HDJQ53030 HDJQ53031 HDJN51333 HDJN51855 HDJN51856 HDJN51857 HDJN51858 HDJN51859 HDJN51692 HDJN50786 HDJN50785 HDJN50787 HDJN50788 HDJQ52080 HDJQ52081 HDJR57435 HDJR57436 HDJR57437 HDJR57438 HDJR57439 HDJR57751 HDJS51416 HDJS51554 HDJS51555 HDJS51556 HDJQ51789 HDJQ51792 HDJM50343 HDJP52606 HDJP52607 HDJM51449 HDJM50903 HDJM50904 HDJM51596 HDJM51597 HDJM51598 HDJM51599 HDJM51759 HDJM51760 HDJM51340 HDJP51984 HDJP51985 HDJP51986 HDJP51987 HDJR54144 HDJQ50029 HDJQ50030 HDJQ50031 HDJQ50032 HDJQ50033 HDJQ50950 HDJR50359 HDJM50199 HDJR56624 HDJR56625 HDJM50867 HDJM50868 HDJM50869 HDJM50870 HDJM50871 HDJM50872 HDJN51772 HDJN51811 HDJN51812 HDJS50702 HDJS51058 HDJS51059 HDJS51060 HDJS51061 HDJS51062 HDJS51063 HDJS51064 HDJR56744 HDJR56745 HDJP52358 HDJM50696 HDJQ52896 HDJS50294 HDJS50295 HDJS50296 HDJN50681 HDJN50680 HDJM50698 HDJN51945 HDJP51921 HDJP51922 HDJP51923 HDJP51924 HDJP51925 HDJN51774 HDJN51775 HDJP51521 HDJP51522 HDJR52096 HDJS52119 HDJS52120 HDJQ51991 HDJM51083 HDJM51896 HDJM52134 HDJM52150 HDJM52151 HDJM52152 HDJM52153 HDJM52154 HDJM52155 HDJP52450 HDJP52451 HDJN50207 HDJN50208 HDJP52083 HDJP52084 HDJP52085 HDJP52086 HDJP52087 HDJP52088 HDJP52089 HDJP52090 HDJP52091 HDJP52092 HDJP52093 HDJP52094 HDJP52095 HDJP52096 HDJP52097 HDJP52098 HDJP52099 HDJP52100 HDJP52101 HDJP52102 HDJR56483 HDJP51566 HDJP50179 HDJQ51046 HDJQ51047 HDJQ50439 HDJQ52816 HDJR50265 HDJR50266 HDJR50267 HDJR50268 HDJR50269 HDJR50270 HDJR50271 HDJR50272 HDJN51147 HDJN51148 HDJN51146 HDJR56262 HDJR56263 HDJM52103 HDJM52104 HDJN51301 HDJM52105 HDJN51526 HDJN51527 HDJN51528 HDJN51529 HDJN51530 HDJN51531 HDJN51532 HDJN51533 HDJN51534 HDJN51535 HDJN51536 HDJN51537 HDJN51538 HDJN51539 HDJN51540 HDJN51541 HDJN51542 HDJN51543 HDJN51544 HDJN51545 HDJN51546 HDJN51547 HDJN51548 HDJN51549 HDJN51550 HDJN51551 HDJN51552 HDJN51553 HDJN51554 HDJN51555 HDJN51556 HDJN51557 HDJN51558 HDJN51559 HDJN51560 HDJN51561 HDJN51562 HDJN51563 HDJN51564 HDJN51565 HDJN51566 HDJN51567 HDJN51568 HDJN51569 HDJN51570 HDJL50363 HDJN52489 HDJN52490 HDJP50858 HDJQ50818 HDJQ52271 HDJS50635 HDJS51324 HDJR52097 HDJM51076 HDJM51077 HDJM51078 HDJS51378 HDJS51379 HDJL50285 HDJL50496 HDJL50497 HDJL50498 HDJL50499 HDJL50500 HDJL50501 HDJL50502 HDJL50503 HDJL50504 HDJM52095 HDJM52097 HDJN50745 HDJN50899 HDJN50900 HDJP51230 HDJP51231 HDJP51232 HDJP51233 HDJP51235 HDJP51236 HDJP51234 HDJP51237 HDJP51238 HDJP51239 HDJP51240 HDJP51241 HDJP52073 HDJP52074 HDJP52075 HDJP52076 HDJP52077 HDJP52078 HDJP52355 HDJP52357 HDJP52734 HDJP52735 HDJN51745 HDJN51746 HDJN51747 HDJS50317 HDJS50318 HDJN50266 HDJP51634 HDJP51635 HDJP51636 HDJP51637 HDJS50536 HDJR57238 HDJN50487 HDJN50488 HDJQ51230 HDJR50707 HDJM50046 HDJM50527 HDJM50955 HDJL50317 HDJL50356 HDJM51066 HDJM51067 HDJM51068 HDJM51070 HDJM51071 HDJM51072 HDJM51073 HDJM51069 HDJM50188 HDJN50597 HDJN50746 HDJN51273 HDJN51274 HDJN51328 HDJR56357 HDJR56379 HDJM51061 HDJM51084 HDJL50278 HDJN52174 HDJN52175 HDJN52176 HDJN52177 HDJN52178 HDJM50673 HDJM50674 HDJR57902 HDJR57903 HDJS51733 HDJS51734 HDJM51406 HDJM51474 HDJQ50384 HDJR57561 HDJR57562 HDJQ51338 HDJQ51339 HDJL50237 HDJL50238 HDJL50239 HDJL50241 HDJL50242 HDJN51779 HDJN51780 HDJN51781 HDJN51782 HDJN51783 HDJR56110 HDJR56111 HDJR56112 HDJR56113 HDJR56114 HDJR56115 HDJR56116 HDJR56117 HDJR56118 HDJR56119 HDJR56120 HDJR56121 HDJR56122 HDJR56123 HDJP52736 HDJP52737 HDJP52738 HDJP52739 HDJP52740 HDJP52741 HDJP52742 HDJP52743 HDJP52744 HDJP52745 HDJQ53048 HDJQ53049 HDJQ53050 HDJL50240 HDJL50243 HDJL50244 HDJL50245 HDJM50063 HDJM51079 HDJM51080 HDJM52050 HDJN52322 HDJN52323 HDJL50521 HDJL50522 HDJL50523 HDJL50491 HDJL50493 HDJL50494 HDJL50517 HDJQ51992 HDJQ52894 HDJQ52903 HDJQ52904 HDJQ52905 HDJQ52907 HDJQ52908 HDJQ52909 HDJQ52910 HDJQ52629 HDJS50899 HDJN51149 HDJN51150 HDJN51151 HDJN51152 HDJR57307 HDJR57308 HDJP50601 HDJP50606 HDJQ52897 HDJQ52108 HDJQ52109 HDJQ52110 HDJQ52111 HDJQ52112 HDJQ52113 HDJQ52877 HDJR56205 HDJR56371 HDJR56372 HDJR56373 HDJR56374 HDJR56667 HDJR56668 HDJR56369 HDJP50216 HDJP50217 HDJP50218 HDJP50219 HDJP50220 HDJP50221 HDJP50222 HDJP50224 HDJP50223 HDJQ51609 HDJQ51610 HDJQ51611 HDJP50635 HDJS50199 HDJS52092 HDJS52093 HDJM51420 HDJM51422 HDJM50436 HDJM50437 HDJM50438 HDJM51438 HDJM51439 HDJM51440 HDJM50580 HDJM50581 HDJM50582 HDJM51682 HDJM51683 HDJM51715 HDJR57968 HDJR57969 HDJR57970 HDJR57971 HDJM50480 HDJM50481 HDJM50482 HDJR57729 HDJQ53076 HDJL50364 HDJN51217 HDJN51218 HDJS52118 HDJQ51343 HDJQ51344 HDJQ51345 HDJQ51346 HDJN51854 HDJP50146 HDJP50178 HDJN51744 HDJM50288 HDJM50289 HDJN51698 HDJR50137 HDJN50593 HDJN50594 HDJR57565 HDJR57566 HDJR57567 HDJR57568 HDJR57569 HDJR57563 HDJR57564 HDJM50695 HDJS50694 HDJS50696 HDJS50736 HDJS50737 HDJM50504 HDJS51325 HDJS51278 HDJS51279 HDJN51210 HDJS52737 HDJS52738 HDJS52739 HDJS52740 HDJM52106 HDJM50536 HDJM50537 HDJQ52617 HDJP50650 HDJP50651 HDJP50652 HDJR50510 HDJR50511 HDJR50512 HDJR50513 HDJR50514 HDJR50515 HDJQ50539 HDJQ52202 HDJQ52203 HDJM51184 HDJM51185 HDJM51186 HDJM51187 HDJM50538 HDJM50956 HDJM50957 HDJM50584 HDJN52351 HDJM51062 HDJM51063 HDJR56626 HDJR56627 HDJR56628 HDJS52715 HDJS52716 HDJQ52906 HDJR57440 HDJP51827 HDJP51828 HDJP51900 HDJM50008 HDJM50009 HDJM50010 HDJM50011 HDJM50421 HDJM50422 HDJP50354 HDJR54218 HDJR58033 HDJR58034 HDJR58035 HDJR58036 HDJM51419 HDJM51421 HDJM51423 HDJM51448 HDJR54219 HDJN50167 HDJN50168 HDJN50169 HDJN50170 HDJR57173 HDJL50195 HDJL50196 HDJL50197 HDJL50198 HDJL50199 HDJL50200 HDJL50201 HDJM51252 HDJM51257 HDJM51259 HDJM51253 HDJM51254 HDJM51255 HDJM51256 HDJM51258 HDJL50422 HDJL50423 HDJN52189 HDJN52190 HDJN52192 HDJN52191 HDJN50237 HDJN50238 HDJN50239 HDJQ50961 HDJQ50962 HDJQ50963 HDJQ50964 HDJQ50965 HDJQ50966 HDJQ50967 HDJQ50968 HDJQ50969 HDJQ50970 HDJQ50971 HDJQ50972 HDJQ50973 HDJQ50974 HDJQ51573 HDJR54164 HDJR54165 HDJR54217 HDJR56714 HDJR52094 HDJM51339 HDJP52018 HDJP52019 HDJP52359 HDJP52363 HDJP52513 HDJP51823 HDJP51824 HDJP51825 HDJP51826 HDJP51829 HDJP51830 HDJP51903 HDJP51904 HDJQ52488 HDJQ52489 HDJS50041 HDJS50616 HDJM50055 HDJM51931 HDJP52809 HDJP52810 HDJQ50153 HDJQ50154 HDJQ50155 HDJP51458 HDJP51459 HDJP51460 HDJQ51306 HDJQ51307 HDJQ51638 HDJQ51639 HDJR52104 HDJR52105 HDJR50765 HDJM51553 HDJM51554 HDJP50353 HDJP50602 HDJS52323 HDJN51946 HDJN51947 HDJQ51634 HDJQ51635 HDJQ51636 HDJQ51637 HDJN51957 HDJP51785 HDJP51786 HDJP51787 HDJP50547 HDJP50548 HDJR50065 HDJR50066 HDJM51794 HDJM52027 HDJM52028 HDJM52029 HDJM52030 HDJM52031 HDJM52032 HDJM52033 HDJM52034 HDJM52035 HDJN51601 HDJR54249 H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51742 HDJP51743 HDJP51744 HDJP51745 HDJP51746 HDJP51747 HDJP51748 HDJQ50873 HDJQ52716 HDJR50657 HDJN51886 HDJP50814 HDJQ50156 HDJR56476 HDJM50662 HDJM50663 HDJM52133 HDJM52281 HDJP50478 HDJP52553 HDJP52554 HDJP52555 HDJP52556 HDJP52557 HDJP52559 HDJS52112 HDJR54000 HDJR56047 HDJM50621 HDJM51555 HDJM51556 HDJM51557 HDJN51669 HDJQ52273 HDJQ52278 HDJQ52274 HDJQ52276 HDJQ52275 HDJQ52277 HDJP50457 HDJP50458 HDJS52595 HDJS52596 HDJS52597 HDJP52707 HDJP52708 HDJP52709 HDJP52710 HDJP52711 HDJQ51154 HDJR54230 HDJR54231 HDJR54232 HDJR56102 HDJR56103 HDJR56817 HDJR56809 HDJR56810 HDJS50633 HDJS50634 HDJM50385 HDJM51279 HDJM51280 HDJM51281 HDJM51814 HDJP52650 HDJQ50702 HDJQ50703 HDJN52100 HDJR50526 HDJR56480 HDJS51252 HDJS51552 HDJM51050 HDJM52136 HDJM52135 HDJM52137 HDJM52157 HDJM52158 HDJM52138 HDJM52255 HDJN50080 HDJN52239 HDJN52127 HDJN52240 HDJP51529 HDJP52648 HDJN50214 HDJN50215 HDJN50216 HDJN50217 HDJR50562 HDJS51334 HDJS51335 HDJS51336 HDJS51337 HDJS51338 HDJS51339 HDJS51340 HDJS51341 HDJS51342 HDJS51343 HDJS51344 HDJS51345 HDJS51346 HDJS51347 HDJS51348 HDJS51349 HDJS51350 HDJS51351 HDJS51352 HDJS51353 HDJS51354 HDJS51355 HDJS51356 HDJS51357 HDJS51358 HDJS51359 HDJS51360 HDJS51361 HDJS51362 HDJS51363 HDJS51364 HDJS51365 HDJS52702 HDJS52703 HDJS52704 HDJS52705 HDJS52706 HDJS52707 HDJS52708 HDJS52709 HDJS52710 HDJS52711 HDJN52228 HDJN52229 HDJN52230 HDJN52231 HDJN52232 HDJN52233 HDJN52234 HDJP51298 HDJP51299 HDJP51300 HDJP51301 HDJP51302 HDJP51303 HDJP52462 HDJP52463 HDJP52514 HDJR56928 HDJS51182 HDJS51183 HDJR56930 HDJS50198 HDJS51144 HDJS51248 HDJS51249 HDJS51250 HDJS51251 HDJS52283 HDJS52399 HDJM52090 HDJN51051 HDJN51052 HDJN51053 HDJP51548 HDJP51549 HDJP51550 HDJP51551 HDJP51552 HDJP51553 HDJQ50441 HDJQ50442 HDJQ52863 HDJQ52864 HDJQ52865 HDJQ52866 HDJQ52867 HDJQ52868 HDJQ52869 HDJQ52870 HDJQ52871 HDJQ52872 HDJQ52873 HDJQ52874 HDJQ52875 HDJQ52876 HDJN50095 HDJN50530 HDJN51496 HDJN51497 HDJN51498 HDJN51499 HDJS50799 HDJQ50249 HDJM50689 HDJM51704 HDJM51705 HDJM51706 HDJM51708 HDJM51703 HDJM51707 HDJM51709 HDJM51710 HDJM52042 HDJM52252 HDJN50339 HDJN50340 HDJN50341 HDJN50342 HDJN50343 HDJN51495 HDJP51712 HDJQ51129 HDJQ51328 HDJR56096 HDJR57203 HDJR57727 HDJS50675 HDJS50700 HDJS50701 HDJS51145 HDJS51146 HDJR52023 HDJR56983 HDJR58244 HDJS50036 HDJS50200 HDJM52256 HDJN51002 HDJN51001 HDJP51259 HDJP51260 HDJP51261 HDJP51262 HDJP51263 HDJP51264 HDJP51265 HDJP51266 HDJR50595 HDJR57243 HDJR57239 HDJR57240 HDJR57241 HDJR57242 HDJR57244 HDJR57245 HDJR57370 HDJR58119 HDJR58120 HDJQ51189 HDJQ51190 HDJQ52808 HDJR56799 HDJR50532 HDJR50533 HDJR50534 HDJR50535 HDJR54273 HDJR56100 HDJR56101 HDJR57371 HDJR57372 HDJR57373 HDJR57374 HDJR57571 HDJN52118 HDJN51637 HDJN51636 HDJP51801 HDJP51555 HDJP52109 HDJQ50063 HDJQ50064 HDJQ50342 HDJQ51188 HDJQ51724 HDJQ51726 HDJQ51727 HDJQ51822 HDJQ51725 HDJQ52023 HDJQ52024 HDJS50299 HDJS50326 HDJS50327 HDJS50328 HDJQ52843 HDJM51940 HDJP50462 HDJP50463 HDJP50464 HDJQ50126 HDJQ50127 HDJQ50128 HDJQ50129 HDJQ50130 HDJQ52400 HDJQ52401 HDJQ52402 HDJS51779 HDJS51780 HDJS51781 HDJS51782 HDJS51783 HDJS51784 HDJS51785 HDJS51786 HDJS51788 HDJS51790 HDJS51791 HDJS51792 HDJS51793 HDJS51794 HDJS51795 HDJS51796 HDJS52102 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  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Uruguay, Venezuela, Albania, Algeria, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Canada, Chile, China, Costa Rica, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Kazakhstan, Korea, Kuwait, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Arab Emirates, and United Kingdom.
  • Product Description
    Giraffe¿ Infant Warmers, part number M1118179, labeled in part *** GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com* || Giraffe¿ Infant Warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    GE Healthcare, 8880 Gorman Rd, Laurel MD 20723-5800
  • Manufacturer Parent Company (2017)
  • Source
    USFDA