{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "176395", "product_res_number": "Z-0167-2020", "event_date_initiated": "2019-09-18", "event_date_created": "2019-10-21", "recall_status": "Terminated", "event_date_terminated": "2021-02-16", "res_event_number": "83804", "product_code": "LHI", "k_numbers": [ "K900585" ], "product_description": "EXACTAMIX Empty EVA (Ethylene Vinyl Acetate) TPN Bag with the following product code and sizes:\n\n1. H938737, 250mL; \n\n2. H938738, 500mL; \n\n3. H938739, 1000mL; \n\n4. H938740, 2000mL; \n\n5. H938741, 3000mL\nProduct Usage: The EXACTAMIX Empty EVA bags are used as the destination container in compounding of large-volume sterile solutions for further administration to a single patient. The empty bags are used at pharmacies and compounding centers by pharmacists and pharmacy technicians to compound multi-ingredient solutions, as prescribed by a physician.", "code_info": "1. UDI Number: 00085412477213, Lot Numbers (60060391, 60061809, 60061816, 60061819, 60063137, 60063138, 60063141, 60063142, 60063143, 60063146, 60063147, 60063148, 60064545, 60064546, 60064547, 60064548, 60064549, 60064551, 60064552, 60064553, 60064554, 60066253, 60066254, 60066255, 60066256, 60066257, 60066258, 60068559, 60070835, 60070836, 60070837, 60074866, 60074955, 60074956, 60074959, 60075125, 60075170, 60080371, 60080372, 60080373, 60080374, 60080375, 60080376, 60081617, 60081618, 60081621, 60081622, 60081649, 60081650, 60081655, 60082887, 60083516, 60083519, 60084461, 60084462, 60084465, 60084466, 60084471, 60084472, 60084475, 60085739, 60085740, 60085741, 60085742, 60085743, 60085744, 60085745, 60086979, 60086980, 60086981, 60086982, 60086985, 60086986, 60088180, 60088181, 60088182, 60088183, 60088185, 60088186, 60089784, 60089785, 60089786, 60089787, 60089788, 60089789, 60091137, 60091138, 60091139, 60091140, 60091141, 60091142, 60092384, 60092407, 60092408, 60092409, 60092410, 60092412, 60093834, 60093835, 60093836, 60093839, 60093841, 60095438, 60095445, 60095446, 60095447, 60096697, 60096698, 60096699, 60096700, 60096701, 60096702, 60097821, 60097822, 60097823, 60097824, 60097825, 60098859, 60098860, 60098861, 60098863,  60098864, 60099739, 60099740, 60099741, 60099742, 60099743, 60099744, 60099745, 60101085, 60101086, 60101099, 60101100, 60101103, 60101104, 60102461, 60102462, 60102463, 60102464, 60102466, 60102467, 60102468, 60103937, 60103938, 60103939, 60103941, 60103942, 60104859, 60105197, 60105198, 60105199, 60105200, 60105201, 60105379, 60105380, 60105389, 60105390, 60105393, 60105394, 60105395, 60106875, 60106877, 60106878, 60106879, 60106880, 60106881, 60108259, 60108260, 60108261, 60108262, 60108263, 60108264, 60108265, 60109537, 60109555, 60109556, 60109561, 60109562, 60109575, 60109576, 60110723, 60110725, 60110726, 60110727, 60110728, 60112087, 60113326, 60113329, 60113331, 60113332, 60113736, 60113737, 60113787, 60113788, 60113790, 60113791, 60114853, 60114855, 60114856, 60115234, 60115237, 60115238, 60115239, 60115240, 60115241, 60115242, 60116219, 60116835, 60116836, 60116843, 60116844, 60116851, 60116857, 60118036, 60118039, 60118040, 60118041, 60118042, 60119280, 60119332, 60119333, 60119375, 60119376, 60119377, 60119380, 60119381, 60119766, 60119781, 60119782, 60119783, 60119785, 60119786, 60120927, 60120928, 60120929, 60120930, 60120931, 60120932, 60120933, 60122722, 60122723, 60122724, 60122725, 60122726, 60122727, 60122728, 60124002, 60124003, 60124004, 60124639, 60124640, 60124641, 60124642, 60124643, 60124644, 60125998, 60125999, 60126000, 60126001, 60126002, 60126003, 60127183, 60127184, 60127185, 60127186, 60127188, 60127189, 60128809, 60128810, 60128849, 60128850, 60128851, 60129801, 60129802, 60129976, 60130029, 60130030, 60130785, 60130786, 60131001, 60131885, 60131886, 60131888, 60131889, 60131909, 60131910, 60131911, 60131913, 60132221, 60132222, 60132223, 60132893, 60132894, 60132895, 60132896, 60132897, 60132898, 60132899, 60132919, 60133465, 60133466, 60133467, 60133468, 60133469, 60134183, 60134184, 60134185, 60134214, 60134215, 60134216, 60134217, 60134218, 60135981, 60135982, 60135983, 60137150, 60137151, 60137152, 60137153, 60137154, 60137155, 60137708, 60137711, 60137823, 60137824, 60137825, 60138236, 60138353, 60138354, 60138359, 60139315, 60139318, 60139319, 60139320, 60140557, 60141754, 60142539, 60142540, 60143045, 60143046, 60143047, 60143048, 60143217, 60143218, 60143219, 60143220, 60143950, 60143951, 60143952, 60143953, 60143954, 60143955, 60145050, 60145444, 60145445, 60145446, 60145447, 60145448, 60145449, 60145450, 60148481, 60149035, 60149036, 60149037, 60149038, 60150445, 60151728, 60151740, 60152505, 60152686, 60152688, 60153376, 60153630, 60153633, 60154180, 60154253, 60154254, 60154259, 60154260, 60154261, 60154306, 60154838, 60154839, 60155183, 60155184, 60155190, 60155195, 60155196, 60155991, 60155993, 60156255, 60156256, 60156257, 60156259, 60157135, 60157136, 60157137, 60157138, 60158786, 60160737, 60160738, 60160741, 60160994, 60161581, 60161583, 60161584, 60161585, 60161587, 60164153, 60164154, 60164155, 60164579, 60165794, 60165795, 60165870, 60165871, 60165872, 60165873, 60166265, 60166266, 60166267, 60166268, 60167288, 60167289, 60167290) Expiration Dates: 04/30/2020 12/31/2021;   2. UDI Number: 00085412477220, Lot Numbers (60049663, 60049703, 60051310, 60052592, 60052693, 60053851, 60053854, 60053855, 60055340, 60055342, 60056343, 60057621, 60057622, 60057623, 60057624, 60057625, 60057626, 60059214, 60059219, 60059220, 60059229, 60059230, 60059241, 60059242, 60060402, 60060423, 60060424, 60060425, 60066392, 60066393, 60066394, 60066395, 60068172, 60068197, 60068198, 60068199, 60068200, 60069106, 60069109, 60069110, 60069112, 60069113, 60070839, 60070840, 60070843, 60070844, 60072120, 60072121, 60072122, 60072125, 60074016, 60074988, 60074991, 60074992, 60075126, 60075172, 60075175, 60075769, 60077611, 60077612, 60077613, 60077614, 60077615, 60079002, 60080311, 60080312, 60080317, 60080318, 60080325, 60080329, 60081682, 60081683, 60081684, 60081685, 60081687, 60082892, 60082895, 60082896, 60084620, 60084629, 60085746, 60085747, 60085748, 60085749, 60085750, 60085751, 60085752, 60086993, 60086994, 60086995, 60086996, 60086997, 60086998, 60088173, 60088175, 60088176, 60088177, 60088178, 60088179, 60089796, 60089797, 60089798, 60091153, 60091154, 60091156, 60091157, 60091158, 60091159, 60092420, 60092423, 60092424, 60092425, 60092426, 60092427, 60094112, 60094115, 60094116, 60094117, 60094118, 60094119, 60095455, 60095456, 60095458, 60095459, 60095460, 60095461, 60096711, 60096712, 60096719, 60096720, 60096721, 60096722, 60096723, 60097834, 60097835, 60097836, 60097837, 60097838, 60097839, 60098879, 60098880, 60098888, 60098897, 60098898, 60099750, 60099751, 60099752, 60099753, 60099754, 60099755, 60099756, 60101125, 60101126, 60101127, 60101128, 60101129, 60101130, 60102476, 60102477, 60102478, 60102479, 60102480, 60102481, 60102482, 60103960, 60103961, 60103962, 60103963, 60105207, 60105208, 60105209, 60105210, 60105415, 60105416, 60105421, 60105524, 60106899, 60106900, 60106901, 60106902, 60106903, 60106904, 60108273, 60108275, 60108276, 60108277, 60108278, 60108279, 60109607, 60109608, 60109615, 60112130, 60112137, 60113232, 60113233, 60113234, 60113235, 60113236, 60115865, 60115866, 60115867, 60115868, 60115869, 60115870, 60116858, 60116871, 60116872, 60116877, 60116878, 60116883, 60116884, 60118054, 60119275, 60119276, 60119277, 60119389, 60119390, 60119391, 60119392, 60119393, 60119394, 60119395, 60119794, 60119795, 60119796, 60119799, 60119800, 60119803, 60119804, 60120941, 60120942, 60120943, 60120944, 60120945, 60120946, 60120951, 60122736, 60122737, 60124015, 60124016, 60124017, 60124018, 60124652, 60124653, 60124654, 60124655, 60124656, 60124657, 60124658, 60126012, 60130818, 60130819, 60131897, 60131898, 60131899, 60132905, 60132906, 60132907, 60132908, 60132909, 60134196,  60134199, 60134200, 60134201, 60135992, 60135993, 60135994, 60135995, 60135996, 60135997, 60137164, 60137165, 60137166, 60137167, 60137713, 60138393, 60138394, 60138402, 60138409, 60140229, 60140565, 60140566, 60141888, 60141890, 60142551, 60142552, 60143503, 60143504, 60143505, 60143506, 60145069, 60145070, 60145457, 60145458, 60145459, 60145460, 60145461, 60145462, 60145463, 60146627, 60146637, 60147002, 60147003, 60147004, 60148490, 60148491, 60148492, 60148493, 60148494, 60148495, 60148496, 60149040, 60149811, 60149812, 60149813, 60149814, 60150425, 60150426, 60150427, 60150428, 60151631, 60151632, 60151651, 60151652, 60151659, 60152677, 60152678, 60153506, 60153707, 60153708, 60154215, 60154216, 60154217, 60154856, 60154859, 60154860, 60154861, 60154862, 60154863, 60154864, 60155172, 60155173, 60155174, 60155175, 60156243, 60156245, 60157738, 60157741, 60157743, 60157744, 60158768, 60158769, 60158770, 60158774, 60159853, 60159854, 60159857, 60160719, 60160720, 60160721, 60160722, 60160723, 60160728, 60161566, 60161567, 60161568, 60161569, 60161571, 60161572, 60162914, 60162951, 60162952, 60162959, 60165790, 60165791, 60165860, 60165863, 60165864, 60165865, 60166255, 60166256, 60166257, 60166258) Expiration Dates: 02/29/2020 12/31/2021;   3. UDI Number: 00085412477237, Lot Numbers (60064180, 60064181, 60064182, 60064183, 60064184, 60064185, 60064186, 60066019, 60069084, 60069099, 60069100, 60069102, 60069103, 60069105, 60072115, 60072118, 60074015, 60074076, 60074077, 60075858, 60075899, 60080378, 60080379, 60080380, 60080381, 60080382, 60081689, 60081690, 60081693, 60081694, 60081705, 60081706, 60082903, 60083520, 60083555, 60084631, 60084633, 60084634, 60084635, 60084636, 60084637, 60085753, 60085754, 60085756, 60085757, 60085758, 60085759, 60085760, 60087000, 60087001, 60087002, 60087003, 60087004, 60087005, 60088210, 60088217, 60088218, 60088221, 60088222, 60088225, 60088226, 60089801, 60089802, 60089803, 60089804, 60095475, 60095476, 60095477, 60095478, 60095479, 60095480, 60095481, 60096724, 60096727, 60096728, 60096729, 60096730, 60096731, 60096732, 60097841, 60097842, 60097843, 60097845, 60097846, 60098899, 60098900, 60098901, 60098903, 60098904, 60110758, 60110759, 60110760, 60110762, 60112138, 60112145, 60112146, 60112153, 60112154, 60113242, 60113245, 60115051, 60115052, 60115053, 60115054, 60115055, 60115056, 60115057, 60115253, 60115254, 60115255, 60115256, 60115257, 60115258, 60115259,  60118569, 60119382, 60119383, 60119384, 60119385, 60119386, 60119387, 60119388, 60120571, 60120572, 60120573, 60124007, 60124009, 60124010, 60124646, 60124647, 60124648, 60124649, 60124650, 60124651, 60125601, 60126004, 60126005, 60126006, 60126007, 60126010, 60127190, 60127192, 60127193, 60127194, 60132900, 60132902, 60132903, 60132904, 60134186, 60134187, 60134188, 60134189, 60134190, 60134191, 60135985, 60135986, 60135988, 60135989, 60135990, 60137712, 60138469, 60140582, 60140847, 60140848, 60140859, 60140869, 60140870, 60142171, 60142172, 60142173, 60142185, 60142547, 60142548, 60145055, 60146999, 60147000, 60147001, 60148484, 60148485, 60148486, 60148487, 60148488, 60148489, 60149800, 60149801, 60149802, 60149805, 60149806, 60151291, 60151292, 60154205, 60154206, 60154207, 60154208, 60154209, 60154210, 60154211, 60154212, 60154213, 60154214, 60155994, 60155995, 60155997, 60155998, 60156219, 60156220, 60156221, 60156222, 60156223, 60156466, 60156467, 60156468, 60157729, 60157730, 60158355, 60158359, 60158417, 60158418, 60158541, 60158749, 60158750, 60158751, 60158752, 60158754, 60158756, 60158759, 60158760, 60158792, 60158795, 60159839, 60159841, 60160682, 60160925, 60160926, 60161397, 60161398, 60161551, 60161552, 60161554, 60161555, 60161556, 60161557, 60161558, 60161559, 60162227, 60162228, 60162873, 60162874, 60162883, 60162884, 60162885, 60162909, 60162910, 60162911, 60162912, 60163509, 60164100, 60164101, 60165786, 60165787, 60165847, 60165848, 60165849, 60165850) Expiration Dates: 04/30/2020 12/31/2021;   4. UDI Number: 00085412477244, Lot Numbers (60048539, 60049820, 60056225, 60056226, 60056227, 60057619, 60059168, 60059170, 60059171, 60059176, 60060435, 60060436, 60060437, 60060438, 60060439, 60061929, 60061930, 60061931, 60061938, 60061939, 60061940, 60061941, 60061942, 60063153, 60063155, 60063156, 60063162, 60063163, 60063164, 60063165, 60063166, 60063169, 60063226, 60064558, 60064578, 60064580, 60064583, 60064584, 60064587, 60066269, 60066275, 60066277, 60066279, 60068134, 60068141, 60068142, 60068163, 60068164, 60068165, 60068166, 60068170, 60069697, 60069699, 60069700, 60069701, 60069702, 60069703, 60069704, 60070833, 60072130, 60072132, 60072134, 60072138, 60073337, 60073338, 60073375, 60073423, 60074713, 60078329, 60078333, 60078398, 60078959, 60078960, 60078961, 60078962, 60078963, 60078964, 60078965, 60078966, 60078967, 60078968, 60078969, 60078971, 60080304, 60080305, 60080306, 60080307, 60081678, 60081680, 60081681, 60083767, 60084476, 60084485, 60084486, 60084489, 60084490, 60084493, 60084494, 60086987, 60086989, 60086990, 60086991, 60086992, 60088197, 60088198, 60088201, 60088202, 60088209, 60089790, 60089791, 60089792, 60089793, 60089794, 60089795, 60091145, 60091146, 60091149, 60091150, 60091151, 60091152, 60092413, 60092414, 60092415, 60092416, 60092417, 60092419, 60094105, 60094106, 60094107, 60094108, 60094109, 60094110, 60094111, 60094663, 60094664, 60095448, 60095449, 60095451, 60095452, 60095453, 60095454, 60096704, 60096705, 60096706, 60096707, 60096709, 60096710, 60097826, 60097827, 60097828, 60097829, 60097830, 60097831, 60098865, 60098866, 60098867, 60098868, 60098869, 60099746, 60099747, 60099748, 60099749, 60101112, 60101123, 60102469, 60102470, 60102471, 60102472, 60102473, 60102474, 60102475, 60103944, 60103953, 60103954, 60103955, 60103956, 60104709, 60104862, 60105212, 60105213, 60105214, 60105215, 60105216, 60105433, 60105441, 60105442, 60105443, 60106891, 60106892, 60106893, 60108269, 60108270, 60109578, 60109579, 60109580, 60109587, 60109588, 60109593, 60110730, 60110733, 60110734, 60110735, 60110737, 60112098, 60112100, 60112106, 60112107, 60113227, 60113228, 60113229, 60113230, 60113231,  60114859, 60115245, 60115247, 60115248, 60115249, 60115251, 60116895, 60116896, 60117290, 60118320, 60118321, 60119334, 60119335, 60119396, 60119398, 60119399, 60119400, 60119401, 60119402, 60119789, 60119791, 60119792, 60120952, 60120959, 60120966, 60120975, 60120976, 60122008, 60122739, 60122740, 60122741, 60124019, 60124020, 60124021, 60124022, 60124621, 60124661, 60124662, 60124663, 60124665, 60124666, 60124667, 60126016, 60126019, 60126021, 60126022, 60126025, 60127209, 60127210, 60127211, 60127212, 60127213, 60128819, 60128820, 60130043, 60130044, 60131900, 60131901, 60131902, 60131903, 60131904, 60131905, 60131931, 60131932, 60132770, 60132771, 60132772, 60132911, 60132912, 60132913, 60132914, 60132916, 60132917, 60134204, 60134210, 60134211, 60134212, 60134213, 60136001, 60136002, 60136003, 60136004, 60136005, 60136006, 60137168, 60137241, 60137242, 60137253, 60137254, 60137265, 60138411, 60138412, 60138413, 60138414, 60138415, 60139335, 60139336, 60139339, 60139340, 60140574, 60140576, 60140577, 60140578, 60141891, 60141892, 60141893, 60141894, 60141897, 60142543, 60143221, 60143222, 60143223, 60143224, 60143226, 60143956, 60143957, 60143958, 60143959, 60143960, 60143961, 60143962, 60145049, 60145465, 60145466, 60145467, 60145468, 60145469, 60147006, 60147007, 60147008, 60147009, 60147010, 60147011, 60148498, 60148499, 60148500, 60150432, 60150433, 60150434, 60150435, 60150437, 60150438, 60150460, 60151673, 60151674, 60151703, 60151704, 60151713, 60151714, 60152680, 60152681, 60152682, 60152683, 60152684, 60152685, 60154218, 60154219, 60154220, 60154221, 60154222, 60154223, 60154224, 60155176, 60155177, 60155178, 60155179, 60155180, 60155181, 60155182, 60156248, 60156250, 60156251, 60156252, 60156253, 60157745, 60157747, 60157748, 60157749, 60158775, 60158777, 60158778, 60158779, 60158780, 60158781, 60159866, 60159881, 60159882, 60159885, 60159886, 60160731, 60160732, 60160734, 60160735, 60160736, 60161575, 60161576, 60161577, 60161578, 60162972) Expiration Dates: 02/29/2020 11/30/2021;   5. UDI Number: 00085412477251, Lot Numbers (60052524, 60056338, 60056340, 60057627, 60064588, 60064591, 60064592, 60064593, 60064597, 60064598, 60064599, 60064603, 60066282, 60066283, 60066287, 60066288, 60066290, 60066293, 60073296, 60073319, 60073331, 60074720, 60078409, 60078972, 60078973, 60078974, 60078975, 60082899, 60082900, 60091160, 60091161, 60091162, 60091163, 60091164, 60091165, 60091167, 60092428, 60092429, 60092430, 60092431, 60092433, 60092434, 60094123, 60094124, 60094125, 60099758, 60099760, 60099761, 60099762, 60101133, 60101134, 60102483, 60102484, 60102486, 60102487, 60102488, 60102489, 60104659, 60104860, 60105202, 60105203, 60105204, 60105205, 60105396, 60105403, 60105405, 60105406, 60105409, 60105410, 60106906, 60106915, 60106916, 60106917, 60106919, 60108443, 60108444, 60108445, 60108446, 60108447, 60108448, 60110492, 60110503, 60110504, 60110505, 60110506, 60110507, 60110508, 60117112, 60117114, 60117115, 60117117, 60118045, 60119884, 60120935, 60120937, 60120940, 60122732, 60122733, 60130038, 60131890, 60131892, 60131893, 60131894, 60132224, 60132232, 60132233, 60137157, 60137158, 60137159, 60137160, 60137161, 60137162, 60138360, 60138373, 60138374, 60138377, 60138378, 60146556, 60146557, 60147815, 60147816, 60147817, 60147818, 60147962, 60147963, 60147964, 60151605, 60151606, 60151611, 60151612, 60152667, 60152668, 60152669, 60152670, 60159843, 60159844, 60159849, 60159850, 60160713) Expiration Dates: 03/31/2020 11/30/2021", "firm_fei_number": "1417572", "recalling_firm": "Baxter Healthcare Corporation", "address_1": "1 Baxter Pkwy", "city": "Deerfield", "state": "IL", "postal_code": "60015-4625", "additional_info_contact": "800-422-9837", "reason_for_recall": "Potential ability to leak once used for compounding.", "root_cause_description": "Process control", "action": "Baxter Healthcare Corporation notified customers on about 09/18/2019, via \"Urgent Product Recall\" letter. The letter informed customers that certain lot numbers of the EXACTAMIX Empty EVA Bags have the potential ability to leak once used for compounding. \n\nCustomers were instructed to locate and remove all affected product lots from your facility, contact Baxter Healthcare Center for Service to arrange for return and credit, complete and return the provided Baxter customer reply form via fax to 224-270-5457 or scanning and e-mailing it to fca@baxter.com, and notify customers or affected personnel/departments if the product was further distributed. For customers who purchased affected product from a distributor, contact your distributor for return and credit. \n\nQuestions can be directed to Baxter Corporate Product Surveillance at 800-437-5176, between the hours of 8:00 am and 5:00 pm Central Time, Monday through Friday.", "product_quantity": "11,389,800 units total", "distribution_pattern": "Worldwide distribution - UD Nationwide including the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.\n\nThe countries of Canada, Australia, New Zealand, Singapore, Korea, Taiwan, Thailand, Hong Kong, Brazil, Columbia, Mexico, Chile, Uruguay, Dominican Republic, Panama, Bermuda.", "openfda": { "k_number": [ "K860703", "K860610", "K213513", "K923966", "K950305", "K091389", "K172631", "K022523", "K923782", "K250345", "K832347", "K926071", "K203674", "K232055", "K920015", 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Fluid Transfer", "medical_specialty_description": "General Hospital", "regulation_number": "880.5440", "device_class": "2" } } ] }