CLASS II Device recall · Reported 1 Jul 2015 · FDA Enforcement Report

Custom Surgical Kits containing Medtronic Covidien recalled

DeRoyal Industries is recalling Custom Surgical Kits containing Medtronic Covidien Devon(TM) Light Gloves: Angio Tray, distributed nationwide in the US. The recall was initiated on 27 Apr 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesREF 50-12127: Lot numbers: 36207249, 36396502, 36912175, 38441725; REF 53-1931: Lot numbers: 33718713, 34910141, 34939139, 35588220, 35814688, 35850671, 35850689, 35862524, 36047791, 36095291, 36517319, 36746146, 36753451, 36517319, 37137174, 36917953, 37581806, 37700140, 37854413, 37794561, 37994256, 38180166, 38222135, 38250970, 38266955, 38475255, 38518382, 36917953; REF 53-1932: Lot numbers: 34374561, 34374570, 34374561, 34492891, 34740023, 34740031, 34910133, 34939067, 34910133, 34939067, 35031309, 35170747, 35503361, 35128080, 35503361, 35128080, 35531442, 35850654, 35850662, 35531442, 35850662, 35862532, 36095267, 36139733, 36426151, 36426169, 36464675, 36746154, 36753442, 36917945, 36746154, 36962762, 37137182, 37137238, 37246240, 37259219, 37287586, 37700123, 37287586, 37581785, 37700158, 37794553, 37869762, 37994230, 38222127, 37700158, 37794553, 37994248, 38222127, 38250945, 38266947, 38475263, 38518374, 37137182, 37259219; 53-1933: Lot numbers: 33718705, 34374545, 34492912, 34939059, 34910125, 34939059, 35086692, 35503337, 35850638, 35850646, 36095259, 36426142, 36746138, 36753434, 36917937, 36962771, 37137166, 37259180, 37287594, 37581769, 37581777, 37854405, 37854421, 37869771, 38467888, 38250937, 37259180; REF 5-3479-1: Lot numbers: 1346014X, 2002010X; REF 89-3605: Lot numbers: 35199494, 35332531, 33714317, 34508890, 34588789, 34701278, 34508890, 35609158, 35733546, 35199494, 35332531, 35609158, 36020265, 36318555, 37012777, 37197994, 37866668, 36740916, 37392423, 37478286, 37652467, 38007267, 38185784, 38497500, 38678503, 34508890; REF 89-3606: Lot numbers: 38086153, 33671273, 33477059, 33804611, 34588797, 34883729, 34508902, 35609166, 35733562, 35095337, 35399517, 35244161, 36053948, 36395614, 36421448, 37198006, 36813661, 37150213, 36665135, 37012785, 37454874, 37652475, 37866676, 38007275, 38160798, 38134063, 38317871, 38275739, 38413062, 38729083; REF 89-3607: Lot numbers: 38221298, 37221034, 33501485, 33478588, 33805577, 34447791, 34785555, 34931903, 34987561, 35610335, 34987561, 35245219, 36207337, 35848642, 36021508, 36479421, 36962244, 37198794, 37455421, 37325992, 37867791, 38086735, 38221298, 38269523, 38498140; REF 89-3609: Lot numbers: 33671281, 34930863, 34588800, 35783990, 35332558, 36318571, 37012793, 37454882, 38086161, 38372184, 38729104; REF 89-3610: Lot numbers: 37866705, 33618931, 33747565, 34508929, 34823689, 35244179, 35784001, 35518184, 35733589, 34959914, 35124804, 35332566, 36020290, 36137236, 36318580, 36053964, 36478428, 36911332, 36813687, 37454891, 38522306, 37267219, 37392440, 37866705, 38038514, 38086170, 38246920, 38275755, 38497526, 38831803, 38609989; REF 89-3611: Lot numbers: 33477083, 33533698, 33692373, 33831257, 34508937, 34737422, 34737414, 35244187, 35733597, 35244195, 35487681, 35896071, 36192569, 36053972, 36478436, 37929711, 36911359, 36543808, 36740959, 37198014, 37454903, 37524060, 37588581, 37274291, 37815035, 38086188, 38185792, 38275763, 38497534, 38729121, 38522314, 38729112, 33477083, 35487681, 36478436, 37929711, 36543808, 37274291, 37815035, 38185792, 38497534; REF 89-3808: Lot numbers: 37198815, 35734821, 33599208, 34510375, 34825140, 35734821, 35459022, 35280250, 35400451, 35734821, 35952141, 36055433, 36479439, 36579860, 36666171, 37013711, 37393080, 37525089, 37867804, 38008008, 38186138, 38221301, 38276344, 38498158, 38781949, 38729884, 35096372, 34510375; REF 89-3809: Lot numbers: 33549278, 33748875, 34510383, 35784731, 35400469, 36666189, 36912511, 37653531, 37378963, 37867812, 38032243, 38345338, 38746246, 37867812; REF 89-4137: Lot numbers: 33692402, 34737502; REF 89-4798: Lot numbers: 37915888, 38086727, 38230397; REF 89-4832: Lot numbers: 34447361, 34589941, 36479199, 37575529, 37839192, 38497948; REF 89-4902: Lot numbers: 34631118, 34750791, 36244744, 37661398, 38401811, 38412991; REF 89-4935: Lot numbers: 37197935, 33533612, 33618907, 33747469, 34431482, 34792675, 33888510, 34930783, 34588711, 35518109, 35659315, 35051537, 35199283, 36318491, 36137172, 36192518, 36020206, 37012742, 36911244, 36576896, 36740801, 37078531, 37454794, 37652408, 38576099, 37741961, 37814930, 37866609, 38007216, 38086102, 38142629, 38246874, 38632417, 38365380; REF 89-5057: Lot numbers: 33669448, 34833123, 35846170, 36017998, 36316285, 37333061, 37813144; REF 89-5059: Lot numbers: 33595653, 33474608, 33618042, 33744858, 35026497, 35242157, 35670944, 35606483, 35039589, 35330851, 35894489, 36316357, 35606483; REF 89-5246: Lot numbers: 33549008, 35896530; REF 89-5259: Lot numbers: 34738556, 34824737, 35518969, 35784458, 35951973, 36396473; REF 89-5609: Lot numbers: 35072602, 35530394, 36132953, 38400051, 38737542; REF 89-5611: Lot numbers: 35514255, 37075882, 37863264; REF 89-5978: Lot number 37263824; REF 89-5979: Lot numbers: 37263841, 34440291, 34682353, 35328436, 37388758; REF 89-5985: Lot numbers: 35560892, 35740244, 34966057, 35946550, 35990921, 36568503, 37622701, 37725494, 37973033, 38219382, 38090697, 38455705, 38743934, 38689131; REF 89-6263: Lot numbers: 38341935, 33616012, 34749079, 35479710, 36068710, 33384258, 33616012, 34749079, 35479710, 36189221, 36068710, 36569055, 37036437, 37194321, 37773496, 38341935, 38778782; REF 89-6264: Lot numbers: 35122585, 36049851, 36132451, 36327187, 36735527, 35122585, 36327187, 36957306, 36661011, 37520376; REF 89-6341: Lot numbers: 33740890, 35239126, 35603101, 37194494, 36735551, 37569639, 37811261; REF 89-6354: Lot numbers: 34749159, 35239151, 37773648; REF 89-6374: Lot numbers: 34352021, 34801412, 34858064, 35728392, 35038359, 36809848, 37194540, 37520430, 38350129, 38399811, 34352021, 34801412, 34858064, 35728392, 35038359, 36809848, 37194540, 37520430, 38350129, 38399811; REF 89-6377: Lot numbers: 33545550, 33689140, 34352047, 34749183, 34858072, 34580402, 34983447, 35513738, 35394759, 35328727, 36049914, 35947149, 36015141, 36079996, 38263261, 36809856, 37145781, 37218249, 36569346, 37075479, 37218249, 37332324, 37463973, 37773701, 37838595, 38090734, 38166410, 37973391, 38342111, 38455941, 38518905, 38630180, 38090734, 33545550, 33689140, 34352047, 34749183, 34858072, 34580402, 34983447, 35513738, 35394759, 35328727, 36049914, 35947149, 36015141, 36079996, 38263261, 36809856, 37145781, 37218249, 36569346, 37075479, 37218249, 37332324, 37463973, 37773701, 37838595, 38090734, 38166410, 37973391, 38342111, 38455941; REF 89-6378: Lot numbers: 35603207, 33565294, 33592188, 33616160, 33740945, 33903193, 34924535, 34352012, 34580381, 34749175, 34858048, 34429171, 34452013, 35603207, 35728384, 34983412, 35122622, 35603207, 35513711, 35328680, 35858808, 35967983, 36262176, 36132540, 36391277, 36473387, 36569311, 36809830, 37145756, 36674955, 37009332, 37520421, 37264270, 37389021, 37773664, 37838587, 38131735, 38084060, 38243930, 38273645, 38495176, 38575504, 35603207, 33565294, 33592188, 33616160, 33740945, 33903193, 34924535, 34352012, 34580381, 34749175, 34858048, 34429171, 34452013, 35603207, 35728384, 34983412, 35122622, 35603207, 35513711, 35328680, 35858808, 35967983, 36262176, 36132540, 36391277, 36473387, 36569311, 36809830, 37145756, 36674955, 37009332, 37520421, 37264270, 37389021, 37773664, 37838587, 38131735, 38084060, 38243930, 38273645; REF 89-6396: Lot numbers: 33592111, 35513640, 37126993, 36868856, 36735535, 37194451, 38495141; REF 89-6409: Lot number 36717054; REF 89-6508: Lot numbers: 36818058, 37217975, 35887289, 33566422, 33688884, 33528400, 33828816, 34523838, 34351749, 34857651, 34868650, 35887289, 34730589, 34579516, 35549651, 35704972, 34966065, 35275725, 35414537, 36686981, 36131889, 35887289, 35959094, 36381837, 36444560, 36904773, 36568511, 36818058, 36877470, 36956952, 37145060, 37378040, 37441854, 37463551, 37519834, 37622719, 38654173, 37862131, 38219391, 38083729, 38243471, 38364897, 38676524, 38526921, 35082296; REF 89-6798: Lot numbers: 35705131, 35428533, 35705131, 35240186, 35428533, 35859085, 37195251, 37774798; REF 89-6799: Lot numbers: 33605971, 35740658, 35705140, 35481730, 36189861, 36263371, 36337617, 33605971, 34581851, 35740658, 35481730, 36189861, 36263371, 36462565, 37146791, 36906699; REF 89-6855: Lot numbers: 33531553, 33669421, 34506237, 35516331, 35093163, 34928253, 35949662, 36476174, 37391017, 37776726, 38745104, 38496419; REF 89-7017: Lot numbers: 35243125, 34671478, 36191751, 37196908, 37651026, 37865391, 38148043, 38780840; REF 89-7018: Lot numbers: 35240805, 33530201, 33593906, 33801146, 33883727, 34733211, 35515258, 35091918, 35948627, 35781417, 35948627, 36392659, 36190230, 36571702, 37147111, 36958536, 37412877, 37323604, 37775432, 37949228, 38132341, 38244924, 38495900, 38630876; REF 89-7020: Lot numbers: 33670511, 34735953, 35243150, 35732210, 35243150, 36052953, 36575295, 36910049, 36960214, 37333280, 37777593, 37950085, 38133386, 38269398, 38344028, 38631887; REF 89-7022: Lot numbers: 37011416, 33802886, 35242392, 35657467, 37011416, 36191312, 37333124, 38133036, 38872699, 38631588; REF 89-7025: Lot numbers: 33532548, 38031339, 33803521, 34671494, 35658216, 35732201, 35517157, 35517165, 35243141, 35339881, 34959164, 36575287, 36664079, 36052945, 36317237, 36960193, 37196916, 37454225, 37651034, 37391623, 37651042, 37865403, 37974141, 38166807, 38229898, 38344010, 38496751, 38745391; REF 89-7026: Lot numbers: 35881135, 34442368, 34504469, 35781425, 34957329, 35240821, 35515266, 35781425, 33667872, 35396279, 35781425, 35604971, 36051133, 36190248, 36315039, 36474849, 36571729, 36571745, 36811112, 36737231, 37010464, 37432966, 37464651, 37648716, 37863969, 37973885, 38178402, 38229450, 38030811, 38342743, 38456046, 38630884, 38779638, 38495918; REF 89-7028: Lot numbers: 33597202, 33887613, 34587364, 34392621, 34882101, 34587364, 35094431, 35517350, 35782920, 36575498, 36910250, 37197054, 38521493, 37651350, 37777753, 37992015, 38160595, 38463799, 38246031; REF 89-7031: Lot numbers: 33530243, 34442448, 34733270, 34819065, 34957353, 35038990, 35240881, 35240899, 35515311, 35730071, 35530440, 35240899, 34957353, 35948694, 36051192, 36133981, 36051192, 36133981, 36392683, 36445431, 36571948, 36571921, 36603401, 36811155, 37010499, 37464677, 37571421, 37195657, 37323655, 37812416, 37775521, 37863985, 37991426, 38193944, 38132375, 38244983, 38342778, 38456089, 38495926, 38630921; REF 89-7058: Lot numbers: 34505971, 34928077, 37021569; REF 89-7061: Lot numbers: 37264878, 33667469, 34925888, 34441605, 35091432, 35514845, 35948248, 36314423, 36570662, 36050771, 37648231, 38630673, 37264878, 37863723, 38274120, 33667469, 33593332; REF 89-7062: Lot numbers: 33746239, 34507660, 34630991, 35782807, 35398434, 35782807, 36394443, 37391615, 38573082, 37741515, 37791344, 37848494, 38496742, 33746239; REF 89-7067: Lot numbers: 33669114, 34820331, 35397247, 36051889, 36662911, 37453628, 37864671, 38343252, 33669114; REF 89-7068: Lot numbers: 34709085, 34506173, 33885693, 35026340, 34506173, 35026340, 35242000, 35782321, 35484332, 35516314, 35093112, 35168284, 35278221, 35397482, 34958217, 35960520, 35894374, 36316218, 36931501, 36573767, 36908766, 37453741, 37477460, 38677771, 37390946, 37649971, 37813128, 37905129, 37991805, 38195317, 38245572, 38132893, 38343341, 38727993, 38520600, 33885693 REF 89-7075: Lot numbers: 33486924, 34735700, 35027334, 35331352, 36191574, 36394283, 36676248, 36959977 REF 89-7076: Lot numbers: 33544848, 33615677, 33781325, 33870619, 34486942, 34351773, 34868772, 35791949, 35801895, 35513201, 35602538, 35751517, 35791949, 34966129, 35501809, 36650961, 36244285, 35928925, 36068437, 36327013, 37057051, 36904837, 36568626, 36603217, 36619551, 36734971, 37476336, 37810832, 37312374, 37948680, 38147833, 38083770, 38243526, 38341687 REF 89-7105: Lot numbers: 37245811, 33530032, 33742502, 34732904, 34874005, 34560428, 35781193, 35515055, 35240565, 35329818, 33883330, 36675456, 36016493, 36050940, 36314829, 36737071, 36811016, 37010384, 36687158, 37400497, 37464520, 37648468, 37648476, 38519676, 37389911, 37824020, 37874537, 37775141, 37991389, 38090873, 38263412, 38365064, 38689499, 34560428 REF 89-7114: Lot numbers: 33486705, 33691266, 33547782, 33802894, 34697328, 34391652, 34391644, 34939577, 34697328, 34670715, 35657475, 35606897, 35731532, 35026825, 35026833, 35093497, 35484914, 35397853, 35484914, 35846321, 35894631, 36052363, 36135530, 36316672, 36328121, 37148412, 36909312, 36476537, 36574305, 36812297, 36663463, 37011424, 37148421, 37453919, 37465346, 35606897, 37650331, 37777041, 37813275, 37949800, 38185371, 38031224, 38133044, 38220316, 38274883, 38245759, 38745227, 38830747, 38520968, 38520976, 38697801; REF 89-7115: Lot numbers: 33546641, 35396092, 34733026, 35396092, 35781257, 36675472, 36288632, 37076404, 36571260, 36958464, 36811075, 37147065, 37195526, 37323461, 37824038, 37775213, 37949156, 38219956, 38132279, 38342655, 38446770, 38744646, 38495854, 38630788; REF 89-7116: Lot Numbers: 34507723, 34671523, 33887322, 34959199, 35094262, 34671523, 34959199, 35782823, 35517190, 35530503, 34959199, 35243176, 35339901, 35517190, 36328340, 36052988, 36191785, 36317288, 36019150, 36394478, 36575332, 36664116, 36960222, 37454233, 37651085, 37413044, 37777614, 37813574, 37324800, 37950093, 38031355, 38178568, 38344044, 38412545, 38496769, 38245960, 38745403, 38831133, 38631908, 33887322, 36191785, 34507723, 35782823; REF 89-7118: Lot numbers: 34818791, 35655429, 35705166, 35396084, 35329869, 36050991, 36571243, 36958456, 38630770, 37648548, 37928911, 38132261, 38711086; REF 89-7189: Lot numbers: 37266363, 35658232, 33803547, 34445235, 33887314, 34536479, 35517173, 35732236, 34929707, 35094254, 35243168, 34929707, 36052961, 36575316, 36664108, 35782815, 36052961, 36317253, 36910057, 37021753, 37465573, 37266363, 37391631, 37777606, 37865411, 38196230, 38031347, 38344036, 38631895, 38521389, 33548136, 33803547; REF 89-7191: Lot numbers: 35657441, 33886291, 34506721, 35657441, 35731508, 35026796, 35331037, 35416381, 36631576, 36052339, 36316664, 36574276, 36631576, 36909267, 37453901, 37650306, 38520950, 37324439, 37777032, 37949789, 38085441, 38274867, 38745201, 33474982, 33547758, 33802860, 33886291; REF 89-7281: Lot numbers: 33881297, 33360521, 33881297, 33903100, 34376137, 34451985, 34923962, 35513210, 35414596, 36131918, 36444607, 36630274, 36818111, 37217983, 38273291, 38494915; REF 89-7301: Lot numbers: 34507766, 35860211, 35243213, 36053024, 37148914, 37865438, 38042901, 38275077; REF 89-7343: Lot numbers: 33597093, 33618675, 33803694, 33860672, 34685394, 34822475, 34671662, 35658398, 35658401, 35027756, 35094385, 35485933, 35398522, 35846743, 35846751, 35846760, 35860262, 35950604, 35992724, 37011803, 36317421, 36317430, 36664167, 37651288, 37699071, 37777729, 37915693, 38042927, 38133431, 38344095, 38496785, 38521469, 38745471, 37699071; REF 89-7390: Lot numbers: 33886186, 35606707, 34958479, 36052283, 37219321, 37465291, 38412262; REF 89-7391: Lot numbers: 34670571, 35093340, 38830641, 35894542, 37864996, 38038397, 38343480, 38830641; REF 89-7398: Lot numbers: 33399257, 33746191, 34586951, 34822205, 34959148, 34507635, 35732172, 35331547, 36019088, 36664044, 35895158, 36317202, 36575252, 36881541, 37011731, 37443825, 37266339, 37333255, 37651000, 37813566, 37777551, 38412529, 38756794, 38521371, 38654747; REF 89-7401: Lot numbers: 34958946, 33817682, 34958946, 35398223, 36317042, 36739325, 38573074, 37865315, 38133327; REF 89-7550: Lot numbers: 33486596, 33802579, 34958292, 36052152, 37021622, 37453791, 37650058, 38148001, 38520722; REF 89-7602: Lot numbers: 35399146, 34741481, 34445868, 34736964, 33888106, 35517931, 34959666, 35399146, 35847421, 36317982, 36740318, 37391990, 37778289, 38185557, 38807432, 38497075, 33888106; REF 89-7620: Lot numbers: 36960724, 34930476, 35399200, 36136997, 36813265, 36576394, 37454639, 38185565, 36960724, 34930476, 35399200, 36136997, 36813265, 36576394, 37454639, 38185565; REF 89-7736: Lot numbers: 34737916, 35544067, 36318846; REF 89-7737: Lot numbers: 35488165, 35609561, 37198284, 37867071; REF 89-7918: Lot numbers: 34931962, 36912600, 36742399, 38086786, 37867901, 38008059, 33619459, 36087056, 33478676, 34354350, 34885759, 34631281, 35610423, 36244841, 36087056, 36124961, 36319531, 37151460, 36912600, 36742399, 36666269, 37653591, 38576443, 37700019, 37867901, 38008059, 38086786, 38142768, 38345354, 38447385, 38498191, 38746254, 38781965, 33478676, 33619459, 34354350, 34561009, 34631281; REF 89-7924: Lot numbers: 37267948, 34673772, 35784829, 35553596, 35400549, 35245340, 36912731, 36545184, 36555340, 36580406, 36742452, 36814680, 37079373, 37151507, 37267930, 38465065, 38807820, 38498211, 38553399, 38633022, 38690078; REF 89-7990: Lot numbers: 34817916, 34503271, 34817916, 34503271, 36810460, 37010026, 37432843, 37905031, 38030598, 37323111; REF 89-7991: Lot numbers: 33471301, 33800557, 34817924, 35481326, 35266423, 35947974, 37010034, 36391971, 36810478, 37323129, 37838683, 37774579, 38132009, 38677236; REF 89-8004: Lot numbers: 33546085, 34487531, 34749440, 34388947, 34872253, 35740623, 35740631, 35654776, 35072629, 35184292, 35240004, 35395356, 35947966, 35991764, 36661636, 36133139, 36314044, 36418564, 36906373, 37076033, 37195075, 37452810, 37570269, 37264704, 37273432, 37400251, 37838675, 37973691, 38084588, 38131997, 38244553, 38273987, 38441055, 38495643, 38519318, 38727281, 38779259; REF 89-8010: Lot numbers: 34429761, 34366351, 36958051, 37146572, 37570285, 38244570, 38519326; REF 89-8191: Lot numbers: 35867894, 35948723, 35887393, 36392712, 38371739; REF 89-8198: Lot number 33546843; REF 89-8249: Lot numbers: 35396578, 38342815, 35396578, 35388404, 38342815, 38446809, 38744742; REF 89-8261: Lot numbers: 34785352, 35605237; REF 89-8273: Lot numbers: 34733464, 34442544, 34733464, 36650443, 36907552, 37864136, 33667995, 34733464, 34390107; REF 89-8308: Lot numbers: 35188293, 36315354, 34875551, 35188293, 36315354, 36675683, 38274429; REF 89-8309: Lot numbers: 36811251, 37218855, 33801541, 34875518, 36811251, 37127427, 37218855, 37265395; REF 89-8310: Lot numbers: 35893718, 36572545, 33500968, 34875315, 35837345, 36134246, 35893718, 36572545, 37521820, 37265379, 38006281; REF 89-8311: Lot numbers: 33501098, 37928996, 38229548, 37195761, 37176780, 33501098, 37928996, 37195761, 38229548, 38496072; REF 89-8372: Lot numbers: 33870900, 33870918, 34583419, 35039108, 36552368, 36717484, 37453281, 38496081, 33870900; REF 89-8379: Lot numbers: 37195809, 37195809, 38245185; REF 89-8394: Lot numbers: 34587874, 34736649, 36317675, 36420867; REF 89-8407: Lot numbers: 34736462, 34952499, 35847017, 36192075, 36910381, 38185442, 38496873, 34587671; REF 89-8409: Lot numbers: 34587698, 34792561, 34952528, 35950719, 35847033; REF 89-8416: Lot numbers: 37777981, 37848700, 37791483, 38275173; REF 89-8444: Lot numbers: 35398725, 35658566, 36053227, 36910348, 36881815, 37149175, 36724545, 37401051, 37454401, 38654771, 37777892, 38091139, 38105393, 37865569, 38091139, 38229986, 38263711, 38344239, 38745534, 38521573, 38553250, 37929243, 38553250; REF 89-8445: Lot numbers: 35398741, 35658582, 37077757, 36317616, 36349001, 36881823, 36575746, 36664301, 37465653, 37651552, 37266507, 37391771, 37661128, 37937534, 38006643, 38133538, 38344255, 37937534, 37465653; REF 89-8464: Lot numbers: 37929286, 37929286, 38160616, 37791491, 38073416, 38288433; REF 89-8465: Lot numbers: 35751832, 35950794, 36019512, 36071100, 35895650, 36337852, 36739974, 37245976, 37454444, 38344301; REF 89-8489: Lot number 38246268; REF 89-8499: Lot numbers: 38246188, 36153447, 36420816, 36812959, 37077802, 36739860, 37324981, 37266531, 38085679, 38142493, 38185451, 38246188; REF 89-8505: Lot numbers: 36291882, 36421333, 38085901; REF 89-8547: Lot numbers: 36960986, 36987610; REF 89-8548: Lot numbers: 36960978, 36987599; REF 89-8549: Lot Numbers: 36987687, 36961129; REF 89-8550: Lot number 36987581; REF 89-8568: Lot numbers: 38497358, 37150088, 37197871, 38497358; REF 89-8652: Lot numbers: 38007195, 38086090; REF 89-8660: Lot number 38371982; REF 89-8664: Lot number 38148094; REF 89-8666: Lot numbers: 38166604, 38245062, 38256597; REF 89-8673: Lot number 38590131; REF 94-0245: Lot numbers: 33530841, 34505269, 33397294, 34390414, 33801955, 34390414, 34505269, 34584075, 35605632, 35483583, 35189472, 35025726, 35605632, 35949179, 36289213, 36811438, 36419591, 36540156, 37010755, 37195972, 37477187, 37522259, 37572192, 37323971, 37824206, 37864460, 38006387, 38132631, 38317417, 38317425, 38343068, 38727791, 38496224; REF 94-0266: Lot numbers: 33534931, 33805551, 35489408, 34960595, 34960595, 37466621, 37506072, 37839248, 38498131, 38729876; REF 94-0277: Lot numbers: 35030349, 36193238, 37839256, 38573234; REF 94-0280: Lot numbers: 36620720, 38807782

Quantity recalled235,785 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1837-2015
FDA event ID: 71294
Recalling firm: DeRoyal Industries, Powell, TN
Classification: Class II
Status: Terminated
Recall initiated: 27 Apr 2015
FDA classified: 25 Jun 2015
Reported: 1 Jul 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Pacemakers & Defibrillators

Timeline

27 Apr 2015	Recall initiated by company
25 Jun 2015	Classified by FDA	+59 days
1 Jul 2015	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Surgical kits contain Medtronic Covidien Devon(TM) Light Gloves which were recalled for splits or holes

Product as listed by the FDA

Custom Surgical Kits containing Medtronic Covidien Devon(TM) Light Gloves: ANGIO TRAY, REF 50-12127; NEURO SPINE TRAY, LAP CHOLE TRACECART(R), REF 53-1931; MINOR PROCEDURE TRACECART (R), REF 53-1932; MAJOR PROCEDURE TRACECART (R), 53-1933; Cover Light Handle Flexible, REF 5-3479-1; LAPAROSCOPY TRAY, REF 89-3605; KNEE/ARTHROSCOPY TRAY, REF 89-3606; SHOULDER/ARTHROSCOPY TRAY, REF 89-3607; LOWER EXTREMITY TRAY, REF 89-3609; BASIC TRAY, REF 89-3610; HAND TRAY, REF 89-3611; NEURO SPINE TRAY, REF 89-3808; NEURO CRANIOTOMY TRAY, REF 89-3809; BASIC SET UP TRAY, REF 89-4137; BASIC PACK, REF 89-4798; SJCHS EXTREMITY TRAY, REF 89-4832; TOTAL KNEE TRAY PGYBK, REF 89-4902; ORTHO SPINE TRAY, REF 89-4935; MAJOR EXTREMITY PACK, REF 89-5057; STANDARD LAP CHOLE PACK, REF 89-5059; UROLOGY CYSTO PACK, REF 89-5246; LAPAROSCOPIC CHOLE PACK, REF 89-5259; FACELIFT & EYELID PACK, REF 89-5609; FACELIFT PACK, REF 89-5611; LAPAROSCOPY PACK, REF 89-5978; HYSTEREOSCOPY TRAY, REF 89-5979; CABG PACK PGYBK A & B, REF 89-5985; OPHTHALMOLOGY PACK PGYBK, REF 89-6263; VASCULAR DRAPE PACK, REF 89-6264; HEART PACK PGYBK, REF 89-6341; SHOULDER PACK, REF 89-6354; MINOR CUSTOM PACK, REF 89-6374; CATARACT PACK PGYBK, REF 89-6377; SURGI-START KIT, REF 89-6378; PACEMAKER PACK, REF 89-6396; GENERAL LAPAROSCOPIC PACK, REF 89-6409; OPEN HEART PROCEDURE PACK TOTAL, REF 89-6508; TOTAL HIP PACK A&B, REF 89-6798; KNEE PACK A&B, REF 89-6799; MAIN OH SUPPLY A&B PACK, REF 89-6855; CRANIOTOMY PACK, REF 89-7017; PACEMAKER PACK, REF 89-7018; GYN MINOR PACK, REF 89-7020; ENT MAJOR PACK, REF 89-7022; GENERAL MAJOR PACK, REF 89-7025; GENERAL MINOR PACK, REF 89-7026; PV PACK, REF 89-7028; GENERAL LAPAROSCOPY PACK, REF 89-7031; CRANIOTOMY PACK, REF 89-7058; LAPAROSCOPY PACK-LF, REF 89-7061; HEAD & NECK PACK, REF 89-7062; VAGINAL HYSTERECTOMY PACK-LF, REF 89-7067; C-SECTION PACK-LF, REF 89-7068; GYN LAPAROSCOPY PACK, REF 89-7075; OPEN HEART PACK, REF 89-7076; C-SECTION PACK, REF 89-7105; TOTAL KNEE PACK, REF 89-7114; ARTHROSCOPY ALL PACK, REF 89-7115; GENERIC ORTHO PACK, REF 89-7116; MINOR EENT PACK, REF 89-7118; COMPANION PACK, REF 89-7189; ENDO VASCULAR PACK, REF 89-7191; OPEN HEART BASIC PACK, REF 89-7281; CUSTOM ER HAND PACK, REF 89-7301; C-SECTION PACK, REF 89-7343; MINOR PACK-LF, REF 89-7390; EXTREMITY PACK, REF 89-7391; ANGIOGRAPHY PACK, REF 89-7398; ANGIOGRAPHY DRAPE PACK PEDI, REF 89-7401; C-SECTION PACK, REF 89-7550; LAMINECTOMY PACK, REF 89-7602; LAPAROSCOPY GEN/UROLOGY PACK, REF 89-7620; LAP CHOLE / APPY TRAY, REF 89-7736; BREAST/TUMMY PACK, REF 89-7737; BASIC PACK, REF 89-7918; LAP CHOLE PACK, REF 89-7924; ROBOTIC SUPPLY URO PACK, REF 89-7990; ROBOTIC SUPPLY GYN PACK, REF 89-7991; SET UP PACK, REF 89-8004; TRAUMA PACK, REF 89-8010; PACEMAKER PACK, REF 89-8191; E HAND PACK, REF 89-8198; NEUROSURGERY PACK, REF 89-8249; SURGERY PACK, REF 89-8261; EYE PACK, REF 89-8273; KNEE PACK, REF 89-8308; SHOULDER PACK, REF 89-8309; HAND PACK, REF 89-8310; PERI/GYN PACK, REF 89-8311; NEURO PACK, REF 89-8372; PODIATRY PACK, REF 89-8379; C-SECTION PACK, REF 89-8394; GENERAL SURGERY PACK, REF 89-8407; GENERAL MALE PACK, REF 89-8409; HAND PACK, REF 89-8416; TOTAL HIP PACK PGYBK, REF 89-8444; TOTAL KNEE PACK PGYBK, REF 89-8445; SURGICAL PODIATRY PACK, REF 89-8464; CATH LAB PACEMAKER PACK, REF 89-8465; BREAST PACK, REF 89-8489; HEAD/NECK PACK, REF 89-8499; EXTREMITY PACK, REF 89-8505; KNEE ARTHROSCOPY PACK, REF 89-8547; SHOULDER ARTHROSCOPY PACK, REF 89-8548; UROLOGY PACK, REF 89-8549; ENT PACK, REF 89-8550; LAMINECTOMY PACK, REF 89-8568; ANT CERV FUSION PACK, REF 89-8652; ENDO BROW FACELIFT PACK, REF 89-8660; PODIATRY PACK, REF 89-8664; GENERAL SURGERY PACK REF 89-8666; Basic Set Up Pack, REF 89-8673; C-SECTION TRAY PGYBK, REF 94-0245; UNIVERSAL BREAST TRAY, REF 94-0266; DR. HAND TRAY, REF 94-0277; FEM-POP TRAY, REF 94-0280 Usage: general surgical

Where it was distributed

Worldwide Distribution: US (nationwide) and country of Guatemala.

Nationwide

Questions about this recall

Is Custom Surgical Kits containing Medtronic Covidien Devon(TM) Light Gloves: Angio Tray recalled?

Yes. DeRoyal Industries recalled Custom Surgical Kits containing Medtronic Covidien Devon(TM) Light Gloves: Angio Tray on 27 Apr 2015. The recall is Class II and its status is Terminated. Recall number Z-1837-2015.

Why was it recalled?

Surgical kits contain Medtronic Covidien Devon(TM) Light Gloves which were recalled for splits or holes

Which lots are affected?

REF 50-12127: Lot numbers: 36207249, 36396502, 36912175, 38441725; REF 53-1931: Lot numbers: 33718713, 34910141, 34939139, 35588220, 35814688, 35850671, 35850689, 35862524, 36047791, 36095291, 36517319, 36746146, 36753451, 36517319, 37137174, 36917953, 37581806, 37700140, 37854413, 37794561, 37994256, 38180166, 38222135, 38250970, 38266955, 38475255, 38518382, 36917953; REF 53-1932: Lot numbers: 34374561, 34374570, 34374561, 34492891, 34740023, 34740031, 34910133, 34939067, 34910133, 34939067, 35031309, 35170747, 35503361, 35128080, 35503361, 35128080, 35531442, 35850654, 35850662, 35531442, 35850662, 35862532, 36095267, 36139733, 36426151, 36426169, 36464675, 36746154, 36753442, 36917945, 36746154, 36962762, 37137182, 37137238, 37246240, 37259219, 37287586, 37700123, 37287586, 37581785, 37700158, 37794553, 37869762, 37994230, 38222127, 37700158, 37794553, 37994248, 38222127, 38250945, 38266947, 38475263, 38518374, 37137182, 37259219; 53-1933: Lot numbers: 33718705, 34374545, 34492912, 34939059, 34910125, 34939059, 35086692, 35503337, 35850638, 35850646, 36095259, 36426142, 36746138, 36753434, 36917937, 36962771, 37137166, 37259180, 37287594, 37581769, 37581777, 37854405, 37854421, 37869771, 38467888, 38250937, 37259180; REF 5-3479-1: Lot numbers: 1346014X, 2002010X; REF 89-3605: Lot numbers: 35199494, 35332531, 33714317, 34508890, 34588789, 34701278, 34508890, 35609158, 35733546, 35199494, 35332531, 35609158, 36020265, 36318555, 37012777, 37197994, 37866668, 36740916, 37392423, 37478286, 37652467, 38007267, 38185784, 38497500, 38678503, 34508890; REF 89-3606: Lot numbers: 38086153, 33671273, 33477059, 33804611, 34588797, 34883729, 34508902, 35609166, 35733562, 35095337, 35399517, 35244161, 36053948, 36395614, 36421448, 37198006, 36813661, 37150213, 36665135, 37012785, 37454874, 37652475, 37866676, 38007275, 38160798, 38134063, 38317871, 38275739, 38413062, 38729083; REF 89-3607: Lot numbers: 38221298, 37221034, 33501485, 33478588, 33805577, 34447791, 34785555, 34931903, 34987561, 35610335, 34987561, 35245219, 36207337, 35848642, 36021508, 36479421, 36962244, 37198794, 37455421, 37325992, 37867791, 38086735, 38221298, 38269523, 38498140; REF 89-3609: Lot numbers: 33671281, 34930863, 34588800, 35783990, 35332558, 36318571, 37012793, 37454882, 38086161, 38372184, 38729104; REF 89-3610: Lot numbers: 37866705, 33618931, 33747565, 34508929, 34823689, 35244179, 35784001, 35518184, 35733589, 34959914, 35124804, 35332566, 36020290, 36137236, 36318580, 36053964, 36478428, 36911332, 36813687, 37454891, 38522306, 37267219, 37392440, 37866705, 38038514, 38086170, 38246920, 38275755, 38497526, 38831803, 38609989; REF 89-3611: Lot numbers: 33477083, 33533698, 33692373, 33831257, 34508937, 34737422, 34737414, 35244187, 35733597, 35244195, 35487681, 35896071, 36192569, 36053972, 36478436, 37929711, 36911359, 36543808, 36740959, 37198014, 37454903, 37524060, 37588581, 37274291, 37815035, 38086188, 38185792, 38275763, 38497534, 38729121, 38522314, 38729112, 33477083, 35487681, 36478436, 37929711, 36543808, 37274291, 37815035, 38185792, 38497534; REF 89-3808: Lot numbers: 37198815, 35734821, 33599208, 34510375, 34825140, 35734821, 35459022, 35280250, 35400451, 35734821, 35952141, 36055433, 36479439, 36579860, 36666171, 37013711, 37393080, 37525089, 37867804, 38008008, 38186138, 38221301, 38276344, 38498158, 38781949, 38729884, 35096372, 34510375; REF 89-3809: Lot numbers: 33549278, 33748875, 34510383, 35784731, 35400469, 36666189, 36912511, 37653531, 37378963, 37867812, 38032243, 38345338, 38746246, 37867812; REF 89-4137: Lot numbers: 33692402, 34737502; REF 89-4798: Lot numbers: 37915888, 38086727, 38230397; REF 89-4832: Lot numbers: 34447361, 34589941, 36479199, 37575529, 37839192, 38497948; REF 89-4902: Lot numbers: 34631118, 34750791, 36244744, 37661398, 38401811, 38412991; REF 89-4935: Lot numbers: 37197935, 33533612, 33618907, 33747469, 34431482, 34792675, 33888510, 34930783, 34588711, 35518109, 35659315, 35051537, 35199283, 36318491, 36137172, 36192518, 36020206, 37012742, 36911244, 36576896, 36740801, 37078531, 37454794, 37652408, 38576099, 37741961, 37814930, 37866609, 38007216, 38086102, 38142629, 38246874, 38632417, 38365380; REF 89-5057: Lot numbers: 33669448, 34833123, 35846170, 36017998, 36316285, 37333061, 37813144; REF 89-5059: Lot numbers: 33595653, 33474608, 33618042, 33744858, 35026497, 35242157, 35670944, 35606483, 35039589, 35330851, 35894489, 36316357, 35606483; REF 89-5246: Lot numbers: 33549008, 35896530; REF 89-5259: Lot numbers: 34738556, 34824737, 35518969, 35784458, 35951973, 36396473; REF 89-5609: Lot numbers: 35072602, 35530394, 36132953, 38400051, 38737542; REF 89-5611: Lot numbers: 35514255, 37075882, 37863264; REF 89-5978: Lot number 37263824; REF 89-5979: Lot numbers: 37263841, 34440291, 34682353, 35328436, 37388758; REF 89-5985: Lot numbers: 35560892, 35740244, 34966057, 35946550, 35990921, 36568503, 37622701, 37725494, 37973033, 38219382, 38090697, 38455705, 38743934, 38689131; REF 89-6263: Lot numbers: 38341935, 33616012, 34749079, 35479710, 36068710, 33384258, 33616012, 34749079, 35479710, 36189221, 36068710, 36569055, 37036437, 37194321, 37773496, 38341935, 38778782; REF 89-6264: Lot numbers: 35122585, 36049851, 36132451, 36327187, 36735527, 35122585, 36327187, 36957306, 36661011, 37520376; REF 89-6341: Lot numbers: 33740890, 35239126, 35603101, 37194494, 36735551, 37569639, 37811261; REF 89-6354: Lot numbers: 34749159, 35239151, 37773648; REF 89-6374: Lot numbers: 34352021, 34801412, 34858064, 35728392, 35038359, 36809848, 37194540, 37520430, 38350129, 38399811, 34352021, 34801412, 34858064, 35728392, 35038359, 36809848, 37194540, 37520430, 38350129, 38399811; REF 89-6377: Lot numbers: 33545550, 33689140, 34352047, 34749183, 34858072, 34580402, 34983447, 35513738, 35394759, 35328727, 36049914, 35947149, 36015141, 36079996, 38263261, 36809856, 37145781, 37218249, 36569346, 37075479, 37218249, 37332324, 37463973, 37773701, 37838595, 38090734, 38166410, 37973391, 38342111, 38455941, 38518905, 38630180, 38090734, 33545550, 33689140, 34352047, 34749183, 34858072, 34580402, 34983447, 35513738, 35394759, 35328727, 36049914, 35947149, 36015141, 36079996, 38263261, 36809856, 37145781, 37218249, 36569346, 37075479, 37218249, 37332324, 37463973, 37773701, 37838595, 38090734, 38166410, 37973391, 38342111, 38455941; REF 89-6378: Lot numbers: 35603207, 33565294, 33592188, 33616160, 33740945, 33903193, 34924535, 34352012, 34580381, 34749175, 34858048, 34429171, 34452013, 35603207, 35728384, 34983412, 35122622, 35603207, 35513711, 35328680, 35858808, 35967983, 36262176, 36132540, 36391277, 36473387, 36569311, 36809830, 37145756, 36674955, 37009332, 37520421, 37264270, 37389021, 37773664, 37838587, 38131735, 38084060, 38243930, 38273645, 38495176, 38575504, 35603207, 33565294, 33592188, 33616160, 33740945, 33903193, 34924535, 34352012, 34580381, 34749175, 34858048, 34429171, 34452013, 35603207, 35728384, 34983412, 35122622, 35603207, 35513711, 35328680, 35858808, 35967983, 36262176, 36132540, 36391277, 36473387, 36569311, 36809830, 37145756, 36674955, 37009332, 37520421, 37264270, 37389021, 37773664, 37838587, 38131735, 38084060, 38243930, 38273645; REF 89-6396: Lot numbers: 33592111, 35513640, 37126993, 36868856, 36735535, 37194451, 38495141; REF 89-6409: Lot number 36717054; REF 89-6508: Lot numbers: 36818058, 37217975, 35887289, 33566422, 33688884, 33528400, 33828816, 34523838, 34351749, 34857651, 34868650, 35887289, 34730589, 34579516, 35549651, 35704972, 34966065, 35275725, 35414537, 36686981, 36131889, 35887289, 35959094, 36381837, 36444560, 36904773, 36568511, 36818058, 36877470, 36956952, 37145060, 37378040, 37441854, 37463551, 37519834, 37622719, 38654173, 37862131, 38219391, 38083729, 38243471, 38364897, 38676524, 38526921, 35082296; REF 89-6798: Lot numbers: 35705131, 35428533, 35705131, 35240186, 35428533, 35859085, 37195251, 37774798; REF 89-6799: Lot numbers: 33605971, 35740658, 35705140, 35481730, 36189861, 36263371, 36337617, 33605971, 34581851, 35740658, 35481730, 36189861, 36263371, 36462565, 37146791, 36906699; REF 89-6855: Lot numbers: 33531553, 33669421, 34506237, 35516331, 35093163, 34928253, 35949662, 36476174, 37391017, 37776726, 38745104, 38496419; REF 89-7017: Lot numbers: 35243125, 34671478, 36191751, 37196908, 37651026, 37865391, 38148043, 38780840; REF 89-7018: Lot numbers: 35240805, 33530201, 33593906, 33801146, 33883727, 34733211, 35515258, 35091918, 35948627, 35781417, 35948627, 36392659, 36190230, 36571702, 37147111, 36958536, 37412877, 37323604, 37775432, 37949228, 38132341, 38244924, 38495900, 38630876; REF 89-7020: Lot numbers: 33670511, 34735953, 35243150, 35732210, 35243150, 36052953, 36575295, 36910049, 36960214, 37333280, 37777593, 37950085, 38133386, 38269398, 38344028, 38631887; REF 89-7022: Lot numbers: 37011416, 33802886, 35242392, 35657467, 37011416, 36191312, 37333124, 38133036, 38872699, 38631588; REF 89-7025: Lot numbers: 33532548, 38031339, 33803521, 34671494, 35658216, 35732201, 35517157, 35517165, 35243141, 35339881, 34959164, 36575287, 36664079, 36052945, 36317237, 36960193, 37196916, 37454225, 37651034, 37391623, 37651042, 37865403, 37974141, 38166807, 38229898, 38344010, 38496751, 38745391; REF 89-7026: Lot numbers: 35881135, 34442368, 34504469, 35781425, 34957329, 35240821, 35515266, 35781425, 33667872, 35396279, 35781425, 35604971, 36051133, 36190248, 36315039, 36474849, 36571729, 36571745, 36811112, 36737231, 37010464, 37432966, 37464651, 37648716, 37863969, 37973885, 38178402, 38229450, 38030811, 38342743, 38456046, 38630884, 38779638, 38495918; REF 89-7028: Lot numbers: 33597202, 33887613, 34587364, 34392621, 34882101, 34587364, 35094431, 35517350, 35782920, 36575498, 36910250, 37197054, 38521493, 37651350, 37777753, 37992015, 38160595, 38463799, 38246031; REF 89-7031: Lot numbers: 33530243, 34442448, 34733270, 34819065, 34957353, 35038990, 35240881, 35240899, 35515311, 35730071, 35530440, 35240899, 34957353, 35948694, 36051192, 36133981, 36051192, 36133981, 36392683, 36445431, 36571948, 36571921, 36603401, 36811155, 37010499, 37464677, 37571421, 37195657, 37323655, 37812416, 37775521, 37863985, 37991426, 38193944, 38132375, 38244983, 38342778, 38456089, 38495926, 38630921; REF 89-7058: Lot numbers: 34505971, 34928077, 37021569; REF 89-7061: Lot numbers: 37264878, 33667469, 34925888, 34441605, 35091432, 35514845, 35948248, 36314423, 36570662, 36050771, 37648231, 38630673, 37264878, 37863723, 38274120, 33667469, 33593332; REF 89-7062: Lot numbers: 33746239, 34507660, 34630991, 35782807, 35398434, 35782807, 36394443, 37391615, 38573082, 37741515, 37791344, 37848494, 38496742, 33746239; REF 89-7067: Lot numbers: 33669114, 34820331, 35397247, 36051889, 36662911, 37453628, 37864671, 38343252, 33669114; REF 89-7068: Lot numbers: 34709085, 34506173, 33885693, 35026340, 34506173, 35026340, 35242000, 35782321, 35484332, 35516314, 35093112, 35168284, 35278221, 35397482, 34958217, 35960520, 35894374, 36316218, 36931501, 36573767, 36908766, 37453741, 37477460, 38677771, 37390946, 37649971, 37813128, 37905129, 37991805, 38195317, 38245572, 38132893, 38343341, 38727993, 38520600, 33885693 REF 89-7075: Lot numbers: 33486924, 34735700, 35027334, 35331352, 36191574, 36394283, 36676248, 36959977 REF 89-7076: Lot numbers: 33544848, 33615677, 33781325, 33870619, 34486942, 34351773, 34868772, 35791949, 35801895, 35513201, 35602538, 35751517, 35791949, 34966129, 35501809, 36650961, 36244285, 35928925, 36068437, 36327013, 37057051, 36904837, 36568626, 36603217, 36619551, 36734971, 37476336, 37810832, 37312374, 37948680, 38147833, 38083770, 38243526, 38341687 REF 89-7105: Lot numbers: 37245811, 33530032, 33742502, 34732904, 34874005, 34560428, 35781193, 35515055, 35240565, 35329818, 33883330, 36675456, 36016493, 36050940, 36314829, 36737071, 36811016, 37010384, 36687158, 37400497, 37464520, 37648468, 37648476, 38519676, 37389911, 37824020, 37874537, 37775141, 37991389, 38090873, 38263412, 38365064, 38689499, 34560428 REF 89-7114: Lot numbers: 33486705, 33691266, 33547782, 33802894, 34697328, 34391652, 34391644, 34939577, 34697328, 34670715, 35657475, 35606897, 35731532, 35026825, 35026833, 35093497, 35484914, 35397853, 35484914, 35846321, 35894631, 36052363, 36135530, 36316672, 36328121, 37148412, 36909312, 36476537, 36574305, 36812297, 36663463, 37011424, 37148421, 37453919, 37465346, 35606897, 37650331, 37777041, 37813275, 37949800, 38185371, 38031224, 38133044, 38220316, 38274883, 38245759, 38745227, 38830747, 38520968, 38520976, 38697801; REF 89-7115: Lot numbers: 33546641, 35396092, 34733026, 35396092, 35781257, 36675472, 36288632, 37076404, 36571260, 36958464, 36811075, 37147065, 37195526, 37323461, 37824038, 37775213, 37949156, 38219956, 38132279, 38342655, 38446770, 38744646, 38495854, 38630788; REF 89-7116: Lot Numbers: 34507723, 34671523, 33887322, 34959199, 35094262, 34671523, 34959199, 35782823, 35517190, 35530503, 34959199, 35243176, 35339901, 35517190, 36328340, 36052988, 36191785, 36317288, 36019150, 36394478, 36575332, 36664116, 36960222, 37454233, 37651085, 37413044, 37777614, 37813574, 37324800, 37950093, 38031355, 38178568, 38344044, 38412545, 38496769, 38245960, 38745403, 38831133, 38631908, 33887322, 36191785, 34507723, 35782823; REF 89-7118: Lot numbers: 34818791, 35655429, 35705166, 35396084, 35329869, 36050991, 36571243, 36958456, 38630770, 37648548, 37928911, 38132261, 38711086; REF 89-7189: Lot numbers: 37266363, 35658232, 33803547, 34445235, 33887314, 34536479, 35517173, 35732236, 34929707, 35094254, 35243168, 34929707, 36052961, 36575316, 36664108, 35782815, 36052961, 36317253, 36910057, 37021753, 37465573, 37266363, 37391631, 37777606, 37865411, 38196230, 38031347, 38344036, 38631895, 38521389, 33548136, 33803547; REF 89-7191: Lot numbers: 35657441, 33886291, 34506721, 35657441, 35731508, 35026796, 35331037, 35416381, 36631576, 36052339, 36316664, 36574276, 36631576, 36909267, 37453901, 37650306, 38520950, 37324439, 37777032, 37949789, 38085441, 38274867, 38745201, 33474982, 33547758, 33802860, 33886291; REF 89-7281: Lot numbers: 33881297, 33360521, 33881297, 33903100, 34376137, 34451985, 34923962, 35513210, 35414596, 36131918, 36444607, 36630274, 36818111, 37217983, 38273291, 38494915; REF 89-7301: Lot numbers: 34507766, 35860211, 35243213, 36053024, 37148914, 37865438, 38042901, 38275077; REF 89-7343: Lot numbers: 33597093, 33618675, 33803694, 33860672, 34685394, 34822475, 34671662, 35658398, 35658401, 35027756, 35094385, 35485933, 35398522, 35846743, 35846751, 35846760, 35860262, 35950604, 35992724, 37011803, 36317421, 36317430, 36664167, 37651288, 37699071, 37777729, 37915693, 38042927, 38133431, 38344095, 38496785, 38521469, 38745471, 37699071; REF 89-7390: Lot numbers: 33886186, 35606707, 34958479, 36052283, 37219321, 37465291, 38412262; REF 89-7391: Lot numbers: 34670571, 35093340, 38830641, 35894542, 37864996, 38038397, 38343480, 38830641; REF 89-7398: Lot numbers: 33399257, 33746191, 34586951, 34822205, 34959148, 34507635, 35732172, 35331547, 36019088, 36664044, 35895158, 36317202, 36575252, 36881541, 37011731, 37443825, 37266339, 37333255, 37651000, 37813566, 37777551, 38412529, 38756794, 38521371, 38654747; REF 89-7401: Lot numbers: 34958946, 33817682, 34958946, 35398223, 36317042, 36739325, 38573074, 37865315, 38133327; REF 89-7550: Lot numbers: 33486596, 33802579, 34958292, 36052152, 37021622, 37453791, 37650058, 38148001, 38520722; REF 89-7602: Lot numbers: 35399146, 34741481, 34445868, 34736964, 33888106, 35517931, 34959666, 35399146, 35847421, 36317982, 36740318, 37391990, 37778289, 38185557, 38807432, 38497075, 33888106; REF 89-7620: Lot numbers: 36960724, 34930476, 35399200, 36136997, 36813265, 36576394, 37454639, 38185565, 36960724, 34930476, 35399200, 36136997, 36813265, 36576394, 37454639, 38185565; REF 89-7736: Lot numbers: 34737916, 35544067, 36318846; REF 89-7737: Lot numbers: 35488165, 35609561, 37198284, 37867071; REF 89-7918: Lot numbers: 34931962, 36912600, 36742399, 38086786, 37867901, 38008059, 33619459, 36087056, 33478676, 34354350, 34885759, 34631281, 35610423, 36244841, 36087056, 36124961, 36319531, 37151460, 36912600, 36742399, 36666269, 37653591, 38576443, 37700019, 37867901, 38008059, 38086786, 38142768, 38345354, 38447385, 38498191, 38746254, 38781965, 33478676, 33619459, 34354350, 34561009, 34631281; REF 89-7924: Lot numbers: 37267948, 34673772, 35784829, 35553596, 35400549, 35245340, 36912731, 36545184, 36555340, 36580406, 36742452, 36814680, 37079373, 37151507, 37267930, 38465065, 38807820, 38498211, 38553399, 38633022, 38690078; REF 89-7990: Lot numbers: 34817916, 34503271, 34817916, 34503271, 36810460, 37010026, 37432843, 37905031, 38030598, 37323111; REF 89-7991: Lot numbers: 33471301, 33800557, 34817924, 35481326, 35266423, 35947974, 37010034, 36391971, 36810478, 37323129, 37838683, 37774579, 38132009, 38677236; REF 89-8004: Lot numbers: 33546085, 34487531, 34749440, 34388947, 34872253, 35740623, 35740631, 35654776, 35072629, 35184292, 35240004, 35395356, 35947966, 35991764, 36661636, 36133139, 36314044, 36418564, 36906373, 37076033, 37195075, 37452810, 37570269, 37264704, 37273432, 37400251, 37838675, 37973691, 38084588, 38131997, 38244553, 38273987, 38441055, 38495643, 38519318, 38727281, 38779259; REF 89-8010: Lot numbers: 34429761, 34366351, 36958051, 37146572, 37570285, 38244570, 38519326; REF 89-8191: Lot numbers: 35867894, 35948723, 35887393, 36392712, 38371739; REF 89-8198: Lot number 33546843; REF 89-8249: Lot numbers: 35396578, 38342815, 35396578, 35388404, 38342815, 38446809, 38744742; REF 89-8261: Lot numbers: 34785352, 35605237; REF 89-8273: Lot numbers: 34733464, 34442544, 34733464, 36650443, 36907552, 37864136, 33667995, 34733464, 34390107; REF 89-8308: Lot numbers: 35188293, 36315354, 34875551, 35188293, 36315354, 36675683, 38274429; REF 89-8309: Lot numbers: 36811251, 37218855, 33801541, 34875518, 36811251, 37127427, 37218855, 37265395; REF 89-8310: Lot numbers: 35893718, 36572545, 33500968, 34875315, 35837345, 36134246, 35893718, 36572545, 37521820, 37265379, 38006281; REF 89-8311: Lot numbers: 33501098, 37928996, 38229548, 37195761, 37176780, 33501098, 37928996, 37195761, 38229548, 38496072; REF 89-8372: Lot numbers: 33870900, 33870918, 34583419, 35039108, 36552368, 36717484, 37453281, 38496081, 33870900; REF 89-8379: Lot numbers: 37195809, 37195809, 38245185; REF 89-8394: Lot numbers: 34587874, 34736649, 36317675, 36420867; REF 89-8407: Lot numbers: 34736462, 34952499, 35847017, 36192075, 36910381, 38185442, 38496873, 34587671; REF 89-8409: Lot numbers: 34587698, 34792561, 34952528, 35950719, 35847033; REF 89-8416: Lot numbers: 37777981, 37848700, 37791483, 38275173; REF 89-8444: Lot numbers: 35398725, 35658566, 36053227, 36910348, 36881815, 37149175, 36724545, 37401051, 37454401, 38654771, 37777892, 38091139, 38105393, 37865569, 38091139, 38229986, 38263711, 38344239, 38745534, 38521573, 38553250, 37929243, 38553250; REF 89-8445: Lot numbers: 35398741, 35658582, 37077757, 36317616, 36349001, 36881823, 36575746, 36664301, 37465653, 37651552, 37266507, 37391771, 37661128, 37937534, 38006643, 38133538, 38344255, 37937534, 37465653; REF 89-8464: Lot numbers: 37929286, 37929286, 38160616, 37791491, 38073416, 38288433; REF 89-8465: Lot numbers: 35751832, 35950794, 36019512, 36071100, 35895650, 36337852, 36739974, 37245976, 37454444, 38344301; REF 89-8489: Lot number 38246268; REF 89-8499: Lot numbers: 38246188, 36153447, 36420816, 36812959, 37077802, 36739860, 37324981, 37266531, 38085679, 38142493, 38185451, 38246188; REF 89-8505: Lot numbers: 36291882, 36421333, 38085901; REF 89-8547: Lot numbers: 36960986, 36987610; REF 89-8548: Lot numbers: 36960978, 36987599; REF 89-8549: Lot Numbers: 36987687, 36961129; REF 89-8550: Lot number 36987581; REF 89-8568: Lot numbers: 38497358, 37150088, 37197871, 38497358; REF 89-8652: Lot numbers: 38007195, 38086090; REF 89-8660: Lot number 38371982; REF 89-8664: Lot number 38148094; REF 89-8666: Lot numbers: 38166604, 38245062, 38256597; REF 89-8673: Lot number 38590131; REF 94-0245: Lot numbers: 33530841, 34505269, 33397294, 34390414, 33801955, 34390414, 34505269, 34584075, 35605632, 35483583, 35189472, 35025726, 35605632, 35949179, 36289213, 36811438, 36419591, 36540156, 37010755, 37195972, 37477187, 37522259, 37572192, 37323971, 37824206, 37864460, 38006387, 38132631, 38317417, 38317425, 38343068, 38727791, 38496224; REF 94-0266: Lot numbers: 33534931, 33805551, 35489408, 34960595, 34960595, 37466621, 37506072, 37839248, 38498131, 38729876; REF 94-0277: Lot numbers: 35030349, 36193238, 37839256, 38573234; REF 94-0280: Lot numbers: 36620720, 38807782

Where was it sold?

Worldwide Distribution: US (nationwide) and country of Guatemala.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from DeRoyal Industries

All 226

Reported	Class	Recall	Company	Reason	Where
10 Jun 2026Device	CLASS II	DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access recalled	DeRoyal Industries	Sterility	Nationwide
12 Mar 2025Device	CLASS II	DeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF recalled	DeRoyal Industries	Foreign Material	5 states
26 Feb 2025Device	CLASS II	DeRoyal AMG Suction Connector Tubing recalled by DeRoyal Industries	DeRoyal Industries	Packaging Defects	21 states
13 Nov 2024Device	CLASS II	DeRoyal C-section Tracepack recalled by DeRoyal Industries	DeRoyal Industries	Other	Nationwide
13 Nov 2024Device	CLASS II	DeRoyal Children's General Tracepack recalled by DeRoyal Industries	DeRoyal Industries	Other	Nationwide

Other Pacemakers & Defibrillators recalls

All 494

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	DermaV Laser System recalled by Lutronic	Lutronic	Other	Nationwide
1 Jul 2026Device	CLASS II	Convenience kits containing select SKUs of Polycarbonate recalled	Medline Industries	Other	Nationwide
24 Jun 2026Device	CLASS II	Medline convenience kits: Loop Pack DYNJ61460C Open Heart recalled	Medline Industries	Device Malfunction	Nationwide
24 Jun 2026Device	CLASS II	Medline convenience kits: Acl Pack DYNJ64161C Arthroscopy recalled	Medline Industries	Foreign Material	Nationwide
24 Jun 2026Device	CLASS II	Medline convenience kits: Bib AV Fistula Pack DYNJ58304B recalled	Medline Industries	Device Malfunction	Nationwide