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U.S. Department of Health and Human Services

Class 1 Device Recall Arrow TwoLumen Central Venous Catheterization Set with Blue FlexTip(R) ARROWgard Blue(R) Catheter

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 Class 1 Recall
Arrow TwoLumen Central Venous Catheterization Set with Blue FlexTip(R) ARROWgard Blue(R) Catheter
see related information
Date Posted June 26, 2012
Recall Status1 Terminated on March 22, 2013
Recall Number Z-1830-2012
Recall Event ID 61915
Premarket Notification
510(K) Number
K900263 
Product Classification Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days - Product Code FOZ
Product Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip(R) ARROWgard Blue(R) Catheter Product Usage: The multiple-lumen catheter permits venous access to central circulation.
Code Information Part numbers (PN) AD-24703 -- lots ZF0088927, ZF0099619, ZF0099893, ZF0100764, ZF0111386, ZF0112205, ZF1013500, ZF1024535, ZF1025078, ZF1036034, ZF1036293, ZF1047553, ZF1068055, ZF1079398, ZF1080286, ZF1091018, ZF1102643, ZF1103235, ZF1113530, ZF1114129, ZF1114632, and ZF2016475. PN AD-24703-OB -- lots ZF1013508, ZF1024536, ZF1025079, ZF1036035, ZF1036449, ZF1057072, ZF1068314, ZF1079528, ZF1080288, ZF1080633, ZF1091019, ZF1092076, ZF1102574, ZF1124769, ZF1124963, ZF1125081, and ZF2016671. PN AD-24730-E -- lots ZF0111748, ZF0122465, ZF1013943, ZF1024429, ZF1035851, ZF1035852, ZF1046809, ZF1047095, ZF1056833, ZF1068324, ZF1068691, ZF1080036, ZF1080307, ZF1091021, ZF1102236, ZF1102876, ZF1113491, ZF1113853, ZF1114656, and ZF1125078. PN AD-24730-OB -- lots ZF0111749, ZF1013521, ZF1024545, ZF1035853, ZF1047096, ZF1056829, ZF1080032, ZF1091022, ZF1125298, ZF1125525, and ZF2016325. PN AD-24730-OL -- lots ZF1013523, ZF1024547, ZF1035855, ZF1056827, ZF1068325, ZF1068941, ZF1080034, ZF1102952, ZF1113498, ZF1114370, and ZF1125517. PN AD-24802 -- lots ZF1025245, ZF1046888, ZF1057494, ZF1068892, ZF1080134, ZF1091014, ZF1091171, ZF1091593, ZF1102950, ZF1113494, ZF1114114, ZF1125215, and ZF2015711. PN AD-24854 -- lots ZF1013537, ZF1024554, ZF1035413, ZF1036310, ZF1046999, ZF1047230, ZF1056918, ZF1057633, ZF1068902, ZF1079269, ZF1079743, ZF1091012, ZF1102545, ZF1103152, ZF1114358, ZF1125139, and ZF2015853. PN AD-24854-NL -- lots ZF1013534, ZF1013996, ZF1035415, ZF1036314, ZF1047232, ZF1056916, ZF1079745, ZF1080316, ZF1080521, and ZF1091239. PN AD-25703 -- lots ZF1013933, ZF1025162, ZF1035869, ZF1036227, ZF1046576, ZF1047364, ZF1068539, ZF1079142, ZF1079563, ZF1102242, ZF1102935, ZF1103232, ZF1113477, ZF1113861, ZF1114337, ZF1114661, and ZF2016129. PN AD-25802-OB -- lots ZF1035537, ZF1057086, ZF1068592, ZF1080274, ZF1080835, ZF1091595, ZF1092074, ZF1102288, ZF1102572, ZF1102786, ZF1125007, and ZF2016072. PN AD-25855 -- lots ZF1047288, ZF1057278, ZF1079689, and ZF1080527. PN AD-26702 -- lots ZF1014152, ZF1035785, ZF1047324, ZF1057505, ZF1079822, ZF1102346, ZF1102553, ZF1113647, ZF2016688, and ZF2016989. PN AG-25854-E -- lots ZF1047326 and ZF1068572. PN ARCS-22122-F -- lot ZF1025264. PN ARCS-22123-F -- lots ZF1025266 and ZF1036280. PN ARCS-22703-E -- lots ZF1025247, ZF1036221, and ZF2016691. PN ARCS-22802 -- lots ZF1025270 and ZF1057860. PN ARCS-22854-E -- lot ZF1035743. PN ARCS-22855 -- lots ZF1035652, ZF1036225, ZF1057858, ZF1102654, ZF1102996, ZF1113529, ZF1114218, ZF1114550, ZF1125252, ZF2015917, and ZF2016589. PN ARCS-25854-E -- lots ZF1025278, ZF1102290, ZF1114403, and ZF1125658. PN ARCS-25855 -- lots ZF1035590, ZF1036253, ZF1102514, and ZF1102997. PN ARCS-25855-E -- lots ZF1025280, ZF1036254, and ZF1102669. PN ARCS-26553 -- lot ZF1067964. PN ARCV-20854 -- lots ZF1025283, ZF1056834, ZF1056967, ZF1057598, ZF1068377, ZF1080368, ZF1102311, ZF1114239, ZF2015767, and ZF2016392. PN ARCV-22703 -- lot ZF1056968. PN ARCV-22854 -- lots ZF1025284, ZF1035655, ZF1056839, ZF1056840, ZF1091568, ZF1091752, ZF1091942, ZF1102158, ZF1102766, ZF1103070, ZF1113771, and ZF1113970. PN ARCV-25854 -- lots ZF1025279 and ZF1056841. PN AT-25854-E -- lots ZF0122759, ZF1013474, ZF1024278, ZF1024618, ZF1035555, ZF1057151, and ZF1079342. PN AT-25855 -- lots ZF1024383, ZF1068063, and ZF1079691. PN AT-25855-E -- lots ZF1013786, ZF1014215, ZF1025016, ZF1036255, ZF1047290, ZF1079687, ZF1080139, ZF1103336, and ZF1113583. PN BB-09903-AG -- lot ZF1035658. PN BB-22122-F -- lots ZF1024651 and ZF1125640. PN BB-22123-F -- lots ZF1013591, ZF1024972, ZF1036278, ZF1047255, ZF1057159, ZF1068380, ZF1079387, ZF1079764, ZF1090994, ZF1102569, ZF1102929, ZF1113525, ZF1113527, ZF1113896, ZF1125296, and ZF2027434. PN B-22853 -- lots ZF1024653, ZF1047631, and ZF1068048. PN BCV-27702-EJT -- lots ZF0090108, ZF0122703, ZF1025028, and ZF1091835. PN CV-27702-ENG -- lots ZF1025030, ZF1036006, ZF1068068, ZF1079360, ZF1091810, ZF1124738, and ZF2016135. PN BERGAMO-25703-E -- lots ZF1013935, ZF1025164, ZF1080637, and ZF2016301. PN BERGAMO-27702-E -- lots ZF1068066, ZF1068387, ZF1079362, and ZF2016323. PN BK-22703 -- lots ZF0099250, ZF0100825, ZF0112082, ZF1013641, ZF1024588, ZF1025250, ZF1047624, ZF1079593, and ZF1125034. PN BL-22702 -- lots ZF1091516, ZF1092045, ZF1103065, ZF1114379, and ZF2017014. PN BL-22703 -- lots ZF1091518, ZF1092078, ZF1103088, and ZF2016667. PN BO-25854 -- lots ZF1013696, ZF1024907, ZF1035642, ZF1036534, ZF1047328, and ZF1079344. PN BR-20854 -- lots ZF1125061 and ZF2016643. PN BR-22703 -- lots ZF0099252, ZF0111422, ZF1024366, ZF1035761, ZF1056835, ZF1068646, ZF1079595, ZF1103344, and ZF1114246. PN BR-22853 -- lots ZF0088532, ZF0122487, ZF1013692, ZF1036027, ZF1068392, ZF1079024, ZF1092015, ZF1103238, and ZF1113994. PN BR-22854 -- lots ZF0088530, ZF0099244, ZF0100823, ZF0111420, ZF0112135, ZF0122421, ZF1013151, ZF1013694, ZF1035334, ZF1046572, ZF1047377, ZF1057193, ZF1068395, ZF1068730, ZF1079839, ZF1090989, ZF1091659, ZF1102184, ZF1102904, ZF1103178, ZF1113451, ZF1125247, ZF2015904, ZF2016516, and ZF2016861. PN BR-24703 -- lots ZF0088640, ZF0099165, ZF0099618, ZF0099896, ZF0100767, ZF0101051, ZF0111518, ZF0111767, ZF0112208, ZF0122625, ZF1013344, ZF1024591, ZF1024820, ZF1036037, ZF1036306, ZF1047078, ZF1047554, ZF1056688, ZF1057083, ZF1068061, ZF1068894, ZF1079530, ZF1080027, ZF1080304, ZF1080635, ZF1091270, ZF1113410, and ZF1114269. PN BR-25703 -- lots ZF0100947, ZF1080794, and ZF2016824. PN BR-25854 -- lots ZF0066888, ZF0088996, ZF0099430, ZF0100330, ZF0100802, ZF0111400, ZF0112163, ZF0122889, ZF1013698, ZF1024906, ZF1036536, ZF1047354, ZF1056910, ZF1068230, ZF1068576, ZF1079347, ZF1080650, ZF1102299, ZF1113582, ZF1114124, ZF1125398, ZF2015914, and ZF2016245. PN BU-25703-E -- lots ZF0099201, ZF0099925, ZF0100816, ZF0111610, ZF0123118, ZF1013931, ZF1024342, ZF1024782, ZF1047099, ZF1057196, ZF1057710, ZF1079144, ZF1080801, ZF1089961, ZF1091219, ZF1102338, ZF1103226, ZF1113505, and ZF2016027. PN CH-24701-H -- lots ZF1091039 and ZF1102281. PN CH-45703-H -- lots ZF1091043 and ZF2016040. PN CH-45854-H -- lots ZF1091037, ZF1102279, and ZF2016053. PN CH-47702-H -- lots ZF1091041 and ZF2016076. PN COMO-27702 -- lots ZF1014147, ZF1025033, ZF1036382, ZF1057098, ZF1068866, and ZF1079452. PN CS-22122-F -- lots ZF0100435, ZF0101091, ZF0111721, ZF0122377, ZF0122774, ZF1014230, ZF1024705, ZF1024966, ZF1025265, ZF1035799, ZF1036198, ZF1046751, ZF1047254, ZF1056804, ZF1057596, ZF1079753, ZF1090912, ZF1102738, ZF1114074, ZF1114663, ZF1124881, ZF1125074, and ZF2016125. PN CS-22123-F -- lots ZF0111725, ZF0122380, ZF0122780, ZF1013593, ZF1013817, ZF1024974, ZF1024975, ZF1035800, ZF1035801, ZF1047258, ZF1057233, ZF1057861, ZF1068676, ZF1079389, ZF1079766, ZF1080049, ZF1091528, ZF1091921, ZF1102134, ZF1102135, ZF1102736, ZF1102737, ZF1103117, ZF1103118, ZF1113794, ZF1114286, ZF1124705, ZF1124877, ZF1125076, and ZF2016809. PN CS- 22802 -- lots ZF1025273, ZF1036224, ZF1047627, ZF1047628, ZF1068415, ZF1079652, ZF1080423, ZF1091399, ZF1091656, ZF1091947, ZF1102887, ZF1103185, ZF1114099, ZF1114316, and ZF2016846. PN CS-22855 -- lots ZF0111621, ZF0122512, ZF0122832, ZF1013766, ZF1024932, ZF1035653, ZF1035654, ZF1036226, ZF1047335, ZF1057264, ZF1057859, ZF1068052, ZF1078999, ZF1080144, ZF1080653, ZF1090966, ZF1091493, ZF1091692, ZF1091914, ZF1102127, ZF1102418, ZF1102811, ZF1103111, ZF1113413, ZF1114530, ZF2016805, and ZF2017180. PN CS-25122-F -- lots ZF0122321 ZF1080697, ZF1013590, ZF1014226, ZF1024704, ZF1024976, ZF1035651, ZF1035803, ZF1047263, ZF1057253, ZF1057595, ZF1079582, ZF1080052, ZF1090913, ZF1090914, ZF1091164, ZF1091963, ZF1102170, ZF1102457, ZF1102852, ZF1113436, ZF1113788, ZF1114051, ZF1114532, ZF1124820, ZF1125472, ZF2016122, and ZF2016798. PN CS-25123-E -- lots ZF1024978, ZF1036334, ZF1047261, ZF1056803, ZF1057856, ZF1079583, ZF1080047, ZF1090915, ZF1091170, ZF1091404, ZF1102285, ZF1102590, ZF1102912, ZF1113832, ZF1114544, ZF1125531, and ZF2016275. PN 25123-F -- lots ZF1014223, ZF1024703, ZF1036335, ZF1047262, ZF1056802, ZF1057255, ZF1057854, ZF1079385, ZF1080053, ZF1080697, ZF1091406, ZF1091967, ZF1102154, ZF1102748, ZF1103165, ZF1113442, ZF1113821, ZF1114541, ZF2016093, ZF2016123, and ZF2016868. PN CS-25402 -- lots ZF1079134, ZF1080044, ZF1080424, ZF1090965, ZF1102785, ZF1113747, and ZF2016979. PN CS-25553 -- lots ZF0090205, ZF1047509, ZF1047510, ZF1057850, ZF1068673, ZF1080425, ZF1103295, ZF1124985, and ZF1125507. PN CS-25703-GRE -- lots ZF1013929, ZF1024502, ZF1025071, ZF1036232, ZF1057451, ZF1057831, ZF1068176, ZF1079158, ZF1080640, ZF1091217, and ZF2027322. PN CS-25802-GRE -- lots ZF1035291, ZF1035782, ZF1057089, ZF1068594, and ZF1079339. PN CS-25853 -- lots ZF0078372, ZF0099664, ZF0100566, ZF0122517, ZF1014035, ZF1024415, ZF1035543, ZF1047337, ZF1057470, ZF1068062, ZF1080357, ZF1091754, ZF1091993, ZF1102200, ZF1102941, ZF1103241, ZF1114123, ZF1114346, ZF1124902, and ZF2016117. PN CS-25853-E -- lots ZF0099665, ZF0100567, ZF0122521, ZF1014036, ZF1025150, ZF1035544, ZF1035546, ZF1047338, ZF1047339, ZF1057471, ZF1068672, ZF1080358, ZF1091088, ZF1091471, ZF1102535, ZF1102900, ZF1103186, ZF1113840, and ZF1114633. PN CS-25855 -- lots ZF0067234, ZF0077675, ZF0078371, ZF0089011, ZF0099964, ZF0100306, ZF0101047, ZF0111537, ZF0112315, ZF0123101, ZF1013795, ZF1024385, ZF1035593, ZF1036262, ZF1047299, ZF1057283, ZF1057665, ZF1068212, ZF1068922, ZF1079696, ZF1080529, ZF1080632, ZF1080886, ZF1091483, ZF1091635, ZF1091899, ZF1102115, ZF1102734, ZF1103103, ZF1113800, ZF1114611, ZF1125157, ZF1125458, ZF2015786, ZF2016285, and ZF2016737. PN CS-25855-E -- ZF0066738, ZF0067233 ZF0078370 ZF0099957 ZF0100704 ZF0111538 ZF0112313 ZF1013794 ZF1014220 ZF1024382 ZF1035591 ZF1035592 ZF1036261 ZF1047298 ZF1057282 ZF1067959 ZF1068921 ZF1079695 ZF1091722 ZF1103170 PN CS-26553 -- lots ZF1047599 ZF1047600 ZF1068065 ZF1080429 ZF1102295 ZF1103242 ZF1124737 ZF2015995 ZF2027334 PN CS-45703-GRE -- lots ZF0090102 and ZF1025040. PN CS-45802-GRE -- lot ZF1046621. PN CV-20854 -- lots ZF1013640 ZF1014171 ZF1036264 ZF1047392 ZF1057071 ZF1080369 ZF1091326 ZF1092056 ZF1102552 ZF1102957 ZF1103381 ZF1113868 ZF1125043 ZF2015749 ZF2016646 PN CV-22703 -- lots ZF0090127 ZF0099254 ZF0100831 ZF0111426 ZF0122419 ZF1013651 ZF1014166 ZF1024374 ZF1025260 ZF1035763 ZF1035764 ZF1036203 ZF1047390 ZF1057334 ZF1057756 ZF1068412 ZF1068648 ZF1079367 ZF1079598 ZF1080399 ZF1080844 ZF1091313 ZF1091562 ZF1091702 ZF1102398 ZF1102799 ZF1103372 ZF1113774 ZF1114529 ZF1125675, and ZF2016118. PN CV-22703-SR -- lots ZF1036201 ZF1080538, and ZF1113946. PN CV-22854 -- lots ZF0088529, ZF0088922, ZF0099245, ZF0099627, ZF0099997, ZF0100824, ZF0100943, ZF0111421, ZF0112137, ZF0122422, ZF1013152, ZF1013695, ZF1014160, ZF1035335, ZF1035336, ZF1046573, ZF1046574, ZF1047378, ZF1068050, ZF1091706, ZF1091939, ZF1102142, ZF1102459, ZF1102740, ZF1113401, and ZF1113772. PN CV-22854-QE -- ZF0088924, ZF0099624, ZF0100941, ZF0111661, ZF1013150, ZF1035333, ZF1047379, ZF1047380, ZF1068399, ZF1080401, ZF1091763, ZF1102960, ZF1113945, ZF1114672, ZF1125528, ZF2015895, and ZF2016952. PN CV-22854-SR -- lots ZF1035331, ZF1036266, ZF1080787, ZF1114391, and ZF2016276. PN CV-24301-E -- lots ZF1013193, ZF1046575, ZF1057514, ZF1057515, ZF1068645, ZF1079838, ZF1080402, ZF1091311, ZF1102272, ZF1103264, ZF1114352, ZF1124916, ZF2015894, ZF2016594, ZF2016897, and ZF2027244. PN CV-24701-E -- lots ZF0100382, ZF1036288, ZF1091765, ZF1102209, ZF1103262, ZF1103263, ZF1113515, ZF1114351, ZF1124915, and ZF1125497. PN CV-24703-E -- lots ZF0090186, ZF0099617, ZF0111764, ZF0122431, ZF1013347, ZF1013812, ZF1024539, ZF1024823, ZF1036038, ZF1036447, ZF1036448, ZF1047470, ZF1057081, ZF1068904, ZF1079604, ZF1091111, ZF1091760, ZF1102210, ZF1103265, and ZF1124718. PN CV-25703 -- lots ZF0077819, ZF0088923, ZF0099745, ZF0100292, ZF0100516, ZF0100819, ZF0100950, ZF0101266, ZF0111801, ZF0112159, ZF0122432, ZF0123123, ZF0123136, ZF1013567, ZF1014141, ZF1025171, ZF1035465, ZF1035773, ZF1035874, ZF1036252, ZF1046584, ZF1047375, ZF1056749, ZF1057319, ZF1057713, ZF1068178, ZF1068545, ZF1079573, ZF1089972, ZF1103098, ZF1113402, ZF1114271, and ZF2015789. PN CV-25854 -- lots ZF0088999, ZF0100338, ZF0100968, ZF0112171, ZF0122891, ZF1013390, ZF1014156, ZF1024905, ZF1035553, ZF1047355, ZF1047589, ZF1057306, ZF1057755, ZF1079354, ZF1079830, ZF1092047, ZF1113558, and ZF2015978. PN CV-25854-LI -- lots ZF1047134, ZF1047136, ZF1068577, ZF1079355, ZF1079831, ZF1080264, and ZF1091542. PN CVD-25703 -- lots ZF1013546, ZF1079048, ZF1080172, ZF1102353, and ZF1103330. PN DE-22123-LMU -- lots ZF1014254, ZF1024449, ZF1025268, ZF1047061, ZF1057161, ZF1057231, ZF1090996, ZF1113568, and ZF2015981. PN DE-22802-GH -- lots ZF1024926, ZF1035716, ZF1057121, and ZF1079654. PN DE-22853-BB -- lot ZF1091049. PN DE-22853-ELOG -- lots ZF0100648, ZF0101156, ZF1024418, ZF1080810, ZF1092022, ZF1113566, and ZF1125392. PN DE-22853-LMU -- lots ZF1014266, ZF1024451, ZF1035522, ZF1067989, ZF1068727, ZF1079027, ZF1079601, ZF1091058, ZF1092006, ZF1102214, ZF1113716, ZF1124724, ZF1124726, ZF1125494, and ZF2016207. PN DE-22854-BB -- lots ZF1091047, ZF1102351, and ZF2016331. PN DE-24701-ELOG -- lots ZF0100650, ZF0101154, ZF1013838, ZF1035560, ZF1036286, ZF1046714, ZF1080236, ZF1091307, ZF1091747, ZF1102225, ZF2015971, ZF2016527. PN DE-24701-GPR -- lot ZF1080234. PN DE-24703-UKO -- lots ZF0112202, ZF0122623, ZF1013348, ZF1024326, ZF1024821, ZF1036039, ZF1047092, ZF1057079, ZF1057670, ZF1079606, ZF1080300, ZF1080768, ZF1102649, ZF1103273, ZF1113930, ZF1114344, ZF1124931, and ZF1125492. PN DE-24730-UKO -- lots ZF1091534, ZF1102515, and ZF2016142. PN DE-24802-UKO -- lots ZF1025058, ZF1047164, ZF1057750, ZF1068890, ZF1080132, ZF1091305, ZF1103022, ZF1103277, ZF1114555, ZF1125315, ZF2015963, and ZF2017020. PN DE-24854-KN -- lot ZF1079080. PN DE-25703-DD -- lots ZF0078113, ZF0088686, ZF0111409, ZF0123112, ZF1013548, ZF1024789, ZF1068543, ZF1079035, ZF1080174, ZF1080642, ZF1102496, ZF1113519, ZF1125231, and ZF2015899. PN DE-25703-GPR -- lots ZF0099206, ZF0099928, ZF0111608, ZF1013927, ZF1024794, ZF1036234, ZF1056744, ZF1068541, and ZF1103279. PN DE-25853-BB -- lot ZF1091045. PN DE-25853-ELOG -- lots ZF0100733, ZF0122351, ZF1014038, ZF1025014, ZF1035547, ZF1046864, ZF1046865, ZF1080659, ZF1090943, ZF1091532, ZF1091954, ZF1102498, ZF1102862, ZF1103169, ZF1125172, ZF2015704, ZF2016389, and ZF2016877. PN DE-25854-BB -- lot ZF1091052. PN DE-25855-ELOG -- lots ZF1079082, ZF1080507, ZF1125353, and ZF2016702. PN DE-26702-GPR -- lot ZF1079050. PN DE-S22703-HZM -- lots ZF1068071, ZF1068515, ZF1113488, and ZF2016706. PN DE-S22853-KOB -- lots ZF0099607, ZF1014135, ZF1024928, ZF1057226, ZF1068393, ZF1079025, and ZF1114395. PN DE-S22854-LMU -- lots ZF1014256, ZF1024453, ZF1047076, ZF1047381, ZF1057329, ZF1102275, ZF1113983, and ZF2015983. PN DE-S25703-DD -- lots ZF0077695, ZF0100690, ZF0112145, ZF0123110, ZF1024786, ZF1035463, ZF1047366, ZF1057199, ZF1057708, ZF1068784, and ZF1079156. PN DK-24702-EK -- lots ZF1068053, ZF1068964, and ZF1091075. PN DK-24703-EK -- lots ZF1035528, ZF1036042, ZF1036296, ZF1047090, ZF1047468, ZF1057076, ZF1068059, ZF1079608, ZF1080298, ZF1080781, ZF1091268, ZF1102549, ZF1102898, ZF1114134, ZF1125389, ZF2015848, and ZF2016480. PN DK-24730-EK -- lots ZF1056825, ZF1057724, ZF1068327, ZF1068939, ZF1080030, ZF1080762, ZF1091536, ZF1102629, ZF1113613, and ZF1124765. PN DU-22703 -- lots ZF1025254, ZF1067965, ZF1068932, ZF1080079, ZF1080394, ZF1080536, ZF1091802, ZF1103285, ZF1113989, ZF1125002, and ZF2016305. PN DU-24706 -- lots ZF1068422, ZF1079408, ZF1080239, ZF1091787, ZF1092016, ZF1103008, and ZF1125575. PN DU-25142-F -- ZF1079037 and ZF2016342. PN EN-24702 -- ZF1080446, ZF1091077, and ZF1102251. PN EN-24730 -- lot ZF1056823. PN EU-22703-IMIN -- ZF2016665. PN EU-24701-EK -- ZF1046712 and ZF1102588. PN EU-24702-EK -- lots ZF1057728, ZF1091859, ZF1114435, and ZF2016131. PN EU-24703-CVT -- lots ZF0100776, ZF1102772, ZF1114552, ZF2015746, and ZF2016617. PN EU-24703-EK -- lots ZF0090188, ZF0111762, ZF1013811, ZF1024322, ZF1024480, ZF1068834, ZF1080297, ZF1080780, ZF1091376, ZF1102565, and ZF1113589. PN EU-24730-EK -- lots ZF1035857, ZF1056821, ZF1057722, ZF1068937, ZF1080305, ZF1080764, ZF1091875, ZF1103299, ZF1124735, and ZF1125511. PN EU-25502-IMIN -- lot ZF1091128. PN EU-25703-CVT -- lots ZF0100775, ZF0111411, ZF1025073, ZF1080177, ZF1113693, and ZF2016336. PN EU-25703-EK -- lots ZF0100814, ZF1013925, ZF1036236, ZF1068782, ZF1091215, and ZF1102228. PN EU-25703-IMIN -- lots ZF0078117, ZF0088688, ZF1102584, and ZF1124719. PN UF-26702 -- lots ZF1046588, ZF1046660, ZF1057507, ZF1079826, ZF1080828, ZF1102249, ZF1102555, ZF1103379, and ZF1124750. PN UW-24703-EK -- lots ZF1025110, ZF1035534, ZF1036055, ZF1036441, ZF1047189, ZF1056680, ZF1068826, ZF1079788, ZF1080770, ZF1102257, ZF1102559, and ZF1113539. PN UW-24854-EK -- lots ZF1035419, ZF1035867, ZF1046997, ZF1047225, ZF1057325, ZF1068841, ZF1079263, ZF1079737, ZF1080308, ZF1080523, ZF1091766, ZF1102233, ZF1102774, ZF1125187, and ZF2015846. PN UW-25855-EK -- lots ZF1035586, ZF1057663, ZF1079679, ZF1103312, and ZF1114223. PN WR-24703 -- lots ZF0078206, ZF0099182, ZF0100951, ZF0111846, ZF0112191, ZF0122619, ZF1025108, ZF1036057, ZF1047081, ZF1047462, ZF1057268, ZF1079790, ZF1080290, ZF1091983, ZF1102846, and ZF1113818. PN ZW-27702-J -- lots ZF1036406, ZF1056668, ZF1079454, ZF1091448, and ZF1125579.
Recalling Firm/
Manufacturer
Arrow International Inc
2400 Bernville Road
Reading, Pennsylvania 19605
Manufacturer Reason
for Recall
Lidstock of product does not contain chlorhexidine contraindication and contains wording "contains no medication" on the label. Product insert does reflect medicated status.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Labeling Mix-Ups
Action Arrow International sent an Urgent Field Corrective Action letter dated May 3, 2012 to their US consignee. The letter identified the affected product, problem and actions to be taken. The letter instructed the consignee to quarantine any affected inventory and relay the information to their Arrow Sales Representative. The letter stated that the Arrow Sales Representative would affix new labels to each kit within their inventory. The consignee was instructed to sign the Acknowledgement Form provided by the Sales Representative which would then be submitted to Arrow. An Urgent Field Safety Notice letter dated May 15, 2012 was sent to foreign consignees with field safety corrective action instructions to follow. If you require additional information or clarification regarding this matter contact your sales representative.
Quantity in Commerce 634,912
Distribution Worldwide Distribution - United States (nationwide) include the state of Texas. and the countries of: ARMENIA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELGIUM, CANADA, CHILE, COLOMBIA, COSTA RICA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, GUATEMALA, HUNGARY, INDIA, ITALY, IRELAND, KENYA, KUWAIT, KYRGYZSTAN, LATVIA, LEBANON, LITHUANIA, LUXEMBOURG, MONTENEGRO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, POLAND, PORTUGAL, QATAR, R®UNION, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWITZERLAND, TURKEY, UKRAINE, , UNITED ARAB EMIRATES and UNITED KINGDOM.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FOZ and Original Applicant = ARROW INTL., INC.
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