—#137247

Product

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

FDA product code: LRO — General Surgery Tray
Device class: Class 2
Medical specialty: General, Plastic Surgery
Affected lot / code info: 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

Why it was recalled

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

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

The firm, DeRoyal, sent an "URGENT! RECALL NOTICE" letter dated 4/27/2015 to their customers (i.e., end-user level, its direct accounts and hospitals) via overnight on 04/27/2015. The letters described the product, problem and actions to be taken. The customers were instructed to do the following: a. send Recall Instructions and a listing of their accounts who were shipped affected product (also included were labels, Training forms, Record of Destruction Forms) b. notify Distributors and Hospitals with a list of products shipped to their account with instructions to place any remaining inventory in quarantine. c. document the lots/quantities labeled at their accounts and complete and return this information on the "Affected Product Listing" to DeRoyal via fax to 865-362-3716 or email to recalls@deroyal.com even if your distributor no longer has any inventory. d. conduct training at the hospitals and this training will be documented on the Recall Training form. e. leave Record of Destruction Forms at the hospital for completion/return to DeRoyal as products are discarded/destroyed. If you have questions or need assistance with the recall, please contact me at 865-362-6465 or tmarsee @deroyal.com.

Recalling firm

Firm: DeRoyal Industries Inc
Address: 200 Debusk Ln, Powell, Tennessee 37849-4703

Distribution

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

Timeline

Recall initiated: 2015-04-27
Posted by FDA: 2015-06-25
Terminated: 2015-12-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #137247. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.