Device Recall Hyfrecator 2000 Electrosurgical Units

Serial Numbers: 1540139, 15280024, 15420101, 15470153, 15510179, 16010007, 1540144, 15280026, 15420102, 15470161, 15510182, 16010008, 15250002, 15290032, 15430106, 15490169, 15510186, 16010009, 15250004, 15290033, 15430107, 15490170, 15510189, 16010010,  15250005, 15300038, 15430110, 15490172, 15510190, 16430108, 15250006, 15350041, 15430111, 15500173, 15510192, 16430109, 15250007, 15350043, 15430113, 15500174, 16010001, 16430112, 15250008, 15350044, 15430114, 15500175, 16010002, 15260010, 15360054, 15430115, 15500176, 16010003, 15260012, 15360057, 15460140, 15500177, 16010004, 15260013, 15360059, 15460142, 15510178, 16010005, 15280023, 15360060, 15460146, 15510179, 16010006.

General and Plastic Surgery Devices

2

No

Worldwide Distribution - US (nationwide) Internationally to Australia, Canada, Germany, Italy, UK, Great Britain, and Ireland.

Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons, 100 VOLTS AC, REF/Catalog Number 7-900-100, Rx Only. There is no problem with the Hyfrecator 2000 Electrosurgical Unit. -- ASSEMBLED IN MEXICO --- CONMED CORPORATION 525 FRENCH ROAD UTICA, NY 13502

Serial Numbers: 1618320 16020102 16070492 16110883 16171279 16231666 16382087 16402485 16442884 16493284 1618330 16020103 16070493 16110884 16171280 16231667 16382088 16412486 16442885 16493285 13181360 16020104 16070494 16110885 16171281 16231668 16382089 16412487 16442886 16493286 15010013 16020105 16070495 16120886 16171282 16231669 16382090 16412488 16442887 16493287 15070434 16020106 16070496 16120887 16171283 16231670 16382091 16412489 16442888 16493288 15221592 16020107 16070497 16120888 16171284 16231671 16382092 16412490 16442889 16493289 15221593 16020108 16070498 16120889 16171285 16231672 16382093 16412491 16442890 16493290 15221594 16020109 16070499 16120890 16171286 16231673 16382094 16412492 16442891 16493291 15221595 16020110 16070500 16120891 16171287 16231674 16382095 16412493 16442892 16493292 15221596 16020111 16080501 16120892 16171288 16231675 16382096 16412494 16442893 16493293 15221597 16020112 16080502 16120893 16171289 16231676 16382097 16412495 16442894 16493294 15221598 16020113 16080503 16120894 16171290 16231677 16382098 16412496 16442895 16493295 15221599 16020114 16080504 16120895 16171291 16231678 16382099 16412497 16442896 16493296 15221600 16020115 16080505 16120896 16171292 16231679 16382100 16412498 16442897 16493297 15240221 16020116 16080506 16120897 16171293 16231680 16382101 16412499 16442898 16493298 15250297 16020117 16080507 16120898 16171294 16231681 16382102 16412500 16442899 16493299 15300642 16020118 16080508 16120899 16171295 16231682 16382103 16412501 16442900 16493301 15300651 16020119 16080509 16120900 16171296 16231683 16382104 16412502 16442901 16493302 15320844 16020120 16080510 16120901 16171297 16231684 16382105 16412503 16442902 16493303 15320846 16020121 16080511 16120902 16171298 16231685 16382106 16412504 16442903 16493304 15320849 16020122 16080512 16120903 16171299 16231686 16382107 16412505 16442904 16493305 15330856 16020123 16080513 16120904 16171300 16231687 16382108 16412506 16442905 16493306 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16020135 16080525 16120916 16171312  16231699 16382120 16412518 16442917 16493318 15351009 16020136 16080526 16120917 16171313 16231700 16382121 16412519 16442918 16493319 15351012 16020137 16080527 16120918 16171314 16231701 16382122 16412520 16442919 16493320 15351014 16020138 16080528 16120919 16171315 16231702 16382123 16412521 16442920 16493321 15351015 16020139 16080529 16120920 16181316 16231703 16382124 16412522 16452921 16493322 15351017 16020140 16080530 16120921 16181317 16231704 16382125 16412523 16452922 16493323 15351019 16030092 16080531 16120922 16181318 16231705 16382126 16412524 16452923 16493324 15351026 16040141 16080532 16120923 16181319 16231706 16382127 16412525 16452924 16493325 15351028 16040142 16080533 16120924 16181321 16231707 16382128 16412526 16452925 16493326 15351030 16040143 16080534 16120925 16181322 16231708 16382129 16412527 16452926 16493327 15401355 16040144 16080535 16120926 16181323 16231709 16382130 16412528 16452927 16493328 15401356 16040145 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16382175 16412573 16452973 16503375 15401401 16040190 16080581 16120972 16181367 16251775 16382176 16412574 16452974 16503376 15401402 16040191 16080582 16120973 16181368 16251776 16382177 16412575 16452975 16503377 15401403 16040192 16080583 16120974 16181369 16251777 16382178 16412576 16452976 16503378 15401404 16040193 16080584 16120975 16181370 16251778 16382179 16412577 16452977 16503379 15411405 16040194 16080585 16120976 16181371 16251779 16382180 16412578 16452978 16503380 15411406 16040195 16080586 16120977 16181372 16251780 16382181 16412579 16452979 16503381 15411407 16040196 16080587 16120978 16181373 16351781 16382182 16412580 16452980 16503382 15411408 16040197 16080588 16120979 16181374 16351782 16382183 16412581 16452981 16503383 15411409 16040198 16080589 16120980 16181375 16351783 16382184 16412582 16452982 16503384 15411410 16040199 16080590 16120981 16181376 16351784 16382185 16412583 16452983 16503385 15411411 16040200 16080591 16120982 16181377 16351785 16382186 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16503409 15492063 16050221 16080612 16121005 16181400 16351808 16392209 16422606 16463006 16503410 15492064 16050222 16080613 16131006 16181401 16351809 16392210 16422607 16463007 16503411 15492065 16050223 16080614 16131007 16181402 16351810 16392211 16422608 16463008 16503412 15492066 16050224 16080615 16131008 16181403 16351811 16392212 16422609 16463009 16503413 15492067 16050225 16090616 16131009 16181404 16351812 16392213 16422610 16463010 16503413 15492068  16050226 16090617 16131010 16181405 16351813 16392214 16422611 16463011 16503414 15492069 16050227 16090618 16131011 16181406 16351814 16392215 16422612 16463012 16503415 15492070 16050228 16090619 16131012 16181407 16351815 16392216 16422613 16463013 16503416 15492071 16050229 16090620 16131013 16181408 16351816 16392217 16422614 16463014 16503418 15492072 16050230 16090621 16131014 16181409 16351817 16392218 16422615 16463015 16503419 15492073 16050231 16090622 16131015 16181410 16351818 16392219 16422616 16463016 16503420 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General and Plastic Surgery Devices

2

No

Worldwide Distribution - US (nationwide) Internationally to Australia, Canada, Germany, Italy, UK, Great Britain, and Ireland.

Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons, 115 VOLTS AC, REF/Catalog Number 7-900-115, Rx Only . There is no problem with the Hyfrecator 2000 Electrosurgical Units. -- ASSEMBLED IN MEXICO --- CONMED CORPORATION 525 FRENCH ROAD UTICA, NY 13502 || The Hyfrecator 2000 Electrosurgical Unit is indicated for use in conjunction with an electrosurgical accessory handpiece for delivery of high frequency electrosurgical current through an accessory electrode for cutting and coagulation at the operative site. The sterile sheaths are intended to cover the electrosurgical handpiece during those typical electrosurgical procedures and reduce the effort necessary to re-sterilize the handpiece between procedures.

Serial Numbers: 1540070, 15450384, 15500476, 16020037, 16150086, 16260128, 16360182, 16450236, 15320037, 15450385, 15500477, 16020038, 16150087, 16260129, 16360183, 16450237, 15330049, 15450386, 15500478, 16020039, 16150088, 16260130, 16360184, 16450238, 15330052, 15450387, 15500479, 16020040, 16150089, 16260131, 16360185, 16450239, 15330053, 15450388, 15500480, 16040041, 16150090, 16260132, 16360186, 16450240, 15340074, 15450389, 15500481, 16040042, 16180091, 16260133, 16360187,  16460241, 15350086, 15450390, 15500482, 16040043, 16180091, 16260134, 16360188, 16460244, 15360096, 15450391, 15500483, 16040044, 16180092, 16260135, 16360189, 16460246, 15360105, 15450392, 15500484, 16040045, 16180092, 16260136, 16360190,  16460248, 15360108, 15450393, 15500485, 16040046, 16180093, 16260137, 16410191, 16460249, 15400254, 15460398, 15500486, 16040047, 16180094, 16260138, 16410192, 16460250, 15400255, 15480434, 15500487, 16040048, 16180095, 16260139, 16410193,  16500266, 15400256, 15480435, 15500488, 16040049, 16180096,  16260140, 16410194, 16500267, 15400257, 15480436, 15500489, 16040050, 16180097, 16260141, 16410195, 16500270, 15400258, 15480437, 15500490, 16040051, 16180098, 16260142, 16410196, 16500271, 15400259, 15480438, 15500491, 16040052, 16180099, 16260143, 16410197, 16500272, 15400260, 15480439, 15500492, 16040053, 16180100, 16260144, 16410198, 16500274, 15400261, 15480440, 15500493, 16040054, 16180101, 16260145, 16410199,  16500275, 15400262, 15480441, 16010001, 16040055, 16180102, 16260146, 16410200, 16500277, 15400263, 15480442, 16010002, 16040056, 16180103, 16260147, 16420201, 16500278, 15400264, 15480443, 16010003, 16040056, 16180104, 16260148, 16420202,  16500279, 15400265, 15480444, 16010004, 16040057, 16180105, 16260149, 16420203, 16500280, 15400266, 15480445, 16010005, 16040057, 16180106, 16260150, 16420204, 154000269, 15400267, 15480446, 16010006, 16040058, 16180107, 16260151, 16420205, 15400268, 15480447, 16010007, 16040058, 16180108, 16260152, 16420206, 15400270, 15480448, 16010008, 16040059, 16180109, 16260153, 16420207, 15400271, 15480449, 16010009, 16040059, 16180110, 16260154, 16420208, 15400272, 15480450, 16010010, 16040060, 16200111, 16260155, 16420209, 15400273, 15480451, 16010011, 16040060, 16200112, 16260156, 16420210, 15400274, 15480452, 16010012, 16040061, 16200113, 16260157, 16430211, 15400275, 15480453, 16010013, 16040062, 16200114, 16260158, 16430212, 15400276, 15480453, 16010014, 16040063, 16200115, 16260159, 16430213, 15400277, 15490454, 16010015, 16040064, 16200116, 16260160, 16430214, 15400278, 15490455, 16010016, 16040065, 16200117, 16260161, 16430215, 15400279, 15490456, 16010017, 16040066, 16200118, 16260162, 16430216, 15400280, 15490457, 16010018, 16040067, 16200119, 16260163, 16430217, 15400281, 15490458, 16010019, 16040068, 16200120, 16260164, 16430218, 15400282, 15490459, 16010020, 16040069, 16220121, 16260165, 16430219, 15400283, 15490460, 16020021, 16040070, 16220122, 16260166, 16430220, 15400284, 15490461, 16020022, 16040071, 16220123, 16260167, 16430221, 15400285, 15490462, 16020023, 16040072, 16220124, 16260168, 16430222, 15400286, 15490463, 16020024, 16040073, 16220125, 16260169, 16430223, 15400287, 15490464, 16020025, 16040074, 16220126, 16260170, 16430224, 15400288, 15490465, 16020026, 16040075, 16220127, 16360171, 16430225, 15410331, 15490466, 16020027, 16040076, 16220128, 16360172, 16430226, 15450374, 15490467, 16020028, 16040077, 16220129, 16360173, 16430227, 15450375, 15490468, 16020029, 16040078, 16220130, 16360174, 16430228, 15450376, 15490469, 16020030, 16040079, 16260121, 16360175, 16430229, 15450377, 15490470, 16020031, 16040080, 16260122, 16360176, 16430230, 15450378, 15490471, 16020032, 16150081, 16260123, 16360177, 16450231, 15450379, 15490472, 16020033, 16150082, 16260124, 16360178, 16450232, 15450380, 15490473, 16020034, 16150083, 16260125, 16360179, 16450233, 15450381, 15500474, 16020035, 16150084, 16260126, 16360180, 16450234, 15450383, 15500475, 16020036, 16150085, 16260127, 16360181, 16450235.

General and Plastic Surgery Devices

2

No

Worldwide Distribution - US (nationwide) Internationally to Australia, Canada, Germany, Italy, UK, Great Britain, and Ireland.

Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons , 220 VOLTS AC, REF/Catalog Number 7-900-220, Rx Only, There is no problem with the Hyfrecator 2000 Electrosurgical Units --- ASSEMBLED IN MEXICO -- CONMED CORPORATION 525 FRENCH ROAD UTICA, NY 13502 ---

Serial Numbers: 1640179, 15500473, 16090084, 16140185, 16170283, 16250376, 16370476, 16380489, 1640180, 15510474, 16090085, 16140186, 16170284, 16250377, 16370477, 16380490, 1640181, 15510475, 16090086, 16140187, 16170285, 16250378, 16370478, 16380491, 1640182, 15510476, 16090087, 16140188, 16170286, 16260379, 16380479, 16380492, 1640183, 15510477, 16090088, 16140189, 16170287, 16260380, 16380480, 16480592, 1640184, 15510478, 16090089, 16140190, 16170288, 16260381, 16380481, 16480593, 1640185, 15510479, 16090090, 16140191, 16170289, 16260382, 16380482, 16480594, 1640186, 15510480, 16090091, 16140192, 16170290, 16260383, 16380483, 16480595, 1640187, 15510481, 16090092, 16140193, 16170291, 16260384, 16380484, 16480596, 1640188, 15510482, 16090093, 16140194, 16170292, 16260385, 16380485, 16480597, 15260015, 15510483, 16090094, 16140195, 16170293, 16260386, 16380486, 16480598, 15260016, 15510484, 16090095, 16140196, 16170294, 16260387, 16380487, 16480599, 15260018, 15510485, 16090096, 16140197, 16170295, 16260388, 16380488, 16500600, 15260020, 15510486, 16090097, 16140198, 16170296, 16260389, 16380493, 16500601, 15260022, 15510487, 16090098, 16150199, 16170297, 16260390, 16430494, 16500602, 15260023, 15510488, 16090099, 16150201, 16170298, 16260391, 16430495, 16500603, 15280038, 15510489, 16090100, 16150202, 16190299, 16260392, 16430496, 16500604, 15280044, 15510490, 16090101, 16150203, 16190300, 16260393, 16430497, 16500605, 15280046, 15510491, 16090102, 16150203, 16190301, 16260394, 16430499, 16500606, 15280048, 15510492, 16090103, 16150204, 16190302, 16260395, 16430500, 16500607, 15280049, 15510493, 16090104, 16150205, 16190303, 16260396, 16430501, 16500608, 15280052, 16010001, 16090105, 16150206, 16190304, 16260397, 16430502, 16500609, 15280053, 16010002, 16090106, 16150207, 16190305, 16260398, 16430503, 16500610, 15280054, 16010003, 16090107, 16150208, 16190306, 16260399, 16430504, 16500611, 15280055, 16010004, 16090108, 16150209, 16190307, 16260400, 16430505, 16500612, 15280056, 16010005, 16090109, 16150210, 16190308, 16260401, 16430506, 16500613, 15280060, 16010006, 16090110, 16150211, 16190309, 16260402, 16430507, 16500614, 15280061, 16010007, 16090111, 16150212, 16190310, 16260403, 16430508, 16500615, 15280062, 16010008, 16090112, 16150213, 16190311, 16260404, 16430509, 16500616, 15280063, 16010009, 16090113, 16150214, 16190312, 16260405, 16430510, 16500617, 15330199, 16010010, 16090114, 16150215, 16190313, 16260406, 16430511, 16500618, 15330200, 16010011, 16090115, 16150216, 16190314, 16260407, 16430512, 16500619, 15330201, 16010012, 16090116, 16150217, 16190315, 16260408, 16430513, 16500637, 15330202, 16010013, 16090117, 16150218, 16190316, 16350409, 16440524, 16510620, 15330203, 16020014, 16090118, 16150219, 16190317, 16350410, 16440525, 16510621, 15340206, 16020015, 16090119, 16150220, 16190318, 16350411, 16440526, 16510622, 15340207, 16020016, 16090120, 16150221, 16210319, 16350412, 16440527, 16510623, 15340208, 16020017, 16090121, 16150222, 16210320, 16350413, 16440528, 16510624, 15340209, 16020018, 16090122, 16150223, 16210321, 16350414, 16440529, 16510626, 15340211, 16020019, 16090123, 16150224, 16210322, 16350415, 16440530, 16510627, 15340212, 16020020, 16110124, 16150225, 16210323, 16350416, 16440531, 16510628, 15340213, 16020021, 16110125, 16150226, 16210324, 16350417, 16440532, 16510630, 15340214, 16020022, 16110126, 16150227, 16210325, 16350418, 16440533, 16510631, 15340215, 16020023, 16110127, 16150228, 16210326, 16350419, 16440534, 16510632, 15340216, 16020024, 16110128, 16150229, 16210327, 16350420, 16440535, 16510633, 15340217, 16020025, 16110129, 16150230, 16210328, 16350421, 16440536, 16510634, 15340218, 16020026, 16110130, 16150231, 16210329, 16350422, 16440537, 16510635, 15340219, 16020027, 16110131, 16150232, 16210330, 16350423, 16440538, 16510638, 15340220, 16020028, 16110132, 16150233, 16210331, 16350424, 16460539, 16510639, 15340221, 16020029, 16110133, 16160234, 16210332, 16350425, 16460540, 16510640, 15340222, 16020030, 16110134, 16160235, 16210333, 16350426, 16460541, 16510641, 15340223, 16020031, 16110135, 16160236, 16210334, 16350427, 16460542, 16510642, 15390363, 16020032, 16110136, 16160237, 16210335, 16350428, 16460543, 16510643, 15390366, 16020033, 16110137, 16160238, 16210336, 16360429, 16460544, 16510645, 15390368, 16020034, 16110138, 16160239, 16210337, 16360430, 16460545, 16510646, 15390369, 16020035, 16110139, 16160240, 16210338, 16360431, 16460546, 16510647, 15390370, 16020036, 16110140, 16160241, 16230322, 16360432, 16460547, 16510648, 15390371, 16020037, 16110141, 16160242, 16230323, 16360433, 16460548, 16510649, 15390372, 16020038, 16110142, 16160243, 16230324, 16360434, 16460550, 16510650, 15390373, 16040109, 16110143, 16160244, 16230325, 16360435, 16460551, 16510653, 15480434, 16050039, 16110144, 16160245, 16230326, 16360436, 16460552, 16510655, 15480435, 16050040, 16110145, 16160246, 16230327, 16360437, 16460553, 16510656, 15480436, 16050041, 16110146, 16160246, 16230328, 16360438, 16460554, 16510657, 15480437, 16050042, 16110147, 16160247, 16230339, 16360439, 16460555, 16510658, 15480438, 16050043, 16110148, 16160247, 16230340, 16360440, 16460556, 16510659, 15480438, 16050044, 16110149, 16160248, 16230341, 16360441, 16460557, 16510662, 15480439, 16050045, 16110150, 16160249, 16230342, 16360442, 16460558, 16510664, 15480440, 16050046, 16110151, 16160250, 16230343, 16360443, 16460559, 16510665, 15480441, 16050047, 16110152, 16160251, 16230344, 16360444, 16460560, 16520672, 15480442, 16050048, 16110153, 16160252, 16230345, 16360445, 16460561, 16520691, 15480443, 16050049, 16110154, 16160253, 16230346, 16360446, 16460562, 15500444, 16050050, 16110155, 16160254, 16230347, 16360447, 16460563, 15500445, 16050051, 16110156, 16160255, 16230348, 16360448, 16460564, 15500446, 16050052, 16110157, 16160256, 16230349, 16360449, 16460565, 15500447, 16050053, 16110158, 16160257, 16230350, 16360450, 16460566, 15500448, 16050054, 16140159, 16160258, 16230351, 16360451, 16460567, 15500449, 16050055, 16140160, 16160259, 16230352, 16360452, 16460568, 15500450, 16050056, 16140161, 16160260, 16230353, 16360453, 16460569, 15500451, 16050057, 16140162, 16160261, 16230354, 16360454, 16470570, 15500452, 16050058, 16140163, 16160262, 16230355, 16360455, 16470571, 15500453, 16050059, 16140164, 16160263, 16230356, 16360456, 16470572, 15500454, 16050060, 16140165, 16170264, 16230357, 16360457, 16470573,  15500455, 16050061, 16140166, 16170265, 16230358, 16360458, 16470574, 15500456, 16050062, 16140167, 16170266, 16250359, 16360459, 16470575, 15500457, 16050063, 16140168, 16170267, 16250360, 16360460, 16470576, 15500458, 16050064, 16140169, 16170268, 16250361, 16360461, 16470577, 15500459, 16050065, 16140170, 16170269, 16250362, 16360462, 16470578, 15500460, 16050066, 16140171, 16170270, 16250363, 16360463, 16470579, 15500461, 16050067, 16140172, 16170271, 16250364, 16360464, 16470580, 15500462, 16050068, 16140173, 16170272, 16250365, 16360465, 16470581, 15500463, 16050069, 16140174, 16170273, 16250366, 16360466, 16470582, 15500464, 16050070, 16140175, 16170274, 16250367, 16360467, 16470583, 15500465, 16050071, 16140176, 16170275, 16250368, 16360468, 16470584, 15500466, 16050072, 16140177, 16170276, 16250369, 16370469, 16470585, 15500467, 16050073, 16140179, 16170277, 16250370, 16370470, 16470586, 15500468, 16050074, 16140180, 16170278, 16250371, 16370471, 16470587, 15500469, 16050075, 16140181, 16170279, 16250372, 16370472, 16470588, 15500470, 16050076, 16140182, 16170280, 16250373, 16370473, 16470589, 15500471, 16050077, 16140183, 16170281, 16250374, 16370474, 16480590, 15500472, 16050078, 16140184, 16170282, 16250375, 16370475, 16480591.

General and Plastic Surgery Devices

2

No

Worldwide Distribution - US (nationwide) Internationally to Australia, Canada, Germany, Italy, UK, Great Britain, and Ireland.

Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons, 230 VOLTS AC, REF/Catalog Number 7-900-230, Rx Only. There is no problem with the Hyfrecator 2000 Electrosurgical Units. -- ASSEMBLED IN MEXICO -- CONMED CORPORATION 525 FRENCH ROAD UTICA, NY 13502