Devices

Device Recall CDI 500 Blood Parameter Monitoring System

  • Model / Serial
    1023, 1025, 1026, 1027, 1029, 1030, 1031, 1034, 1035, 1037, 1040, 1045, 1048, 1054, 1055, 1056, 1057, 1060, 1061, 1062, 1065, 1072, 1073, 1074, 1076, 1077, 1078, 1079, 1080, 1081, 1082, 1083, 1084, 1085, 1086, 1087, 1088, 1089, 1090, 1091, 1092, 1093, 1094, 1095, 1098, 1099, 1100, 1106, 1107, 1108, 1109, 1110, 1114, 1116, 1117, 1118, 1119, 1120, 1121, 1122, 1123, 1124, 1125, 1126, 1127, 1128, 1131, 1132, 1141, 1142, 1143, 1144, 1145, 1154, 1155, 1156, 1157, 1158, 1159, 1160, 1161, 1162, 1164, 1165, 1169, 1170, 1171, 1173, 1174, 1175, 1176, 1177, 1178, 1179, 1180, 1186, 1187, 1188, 1189, 1190, 1191, 1194, 1195, 1197, 1198, 1199, 1200, 1201, 1203, 1204, 1205, 1206, 1207, 1208, 1209, 1210, 1213, 1214, 1215, 1221, 1222, 1223, 1224, 1225, 1226, 1227, 1228, 1229, 1230, 1236, 1237, 1238, 1242, 1249, 1250, 1251, 1252, 1253, 1256, 1257, 1258, 1259, 1260, 1265, 1266, 1267, 1268, 1275, 1278, 1279, 1280, 1281, 1283, 1284, 1290, 1291, 1292, 1293, 1294, 1300, 1301, 1302, 1303, 1304, 1310, 1311, 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  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries of : Australia, Barbados, Belgium, Brazil, Columbia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatamala, Hong Kong, Honduras, Jordan, Japan, Libya, Mexico, Malaysia, Panama, PH, Saudi Arabia, Singapore, South Africa, Thailand, Trinidad, Taiwan and Uruguay, Germany, Saudia Arabia, Paraguay, South Korea, Dominican Republic, Phillipines, South Africa and UAE.
  • Product Description
    CDI Blood Parameter Monitoring System 500 with Arterial blood parameter module and Hematocrit/Saturation probe, Catalog 500AHCT, Terumo Cardiovascular Systems Corporations, Ann Arbor, MI. || The CDI 500 is indicated for use to display patient blood gas values during extracorporeal procedures.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation
  • 1 Event

Manufacturer

Terumo Cardiovascular Systems Corporation
  • Manufacturer Address
    Terumo Cardiovascular Systems Corporation, 6200 Jackson Road, Ann Arbor MI 48103-9586
  • Manufacturer Parent Company (2017)
    Terumo Corp.
  • Source
    USFDA

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Device Recall CDI 500 Blood Parameter Monitoring System
  • Model / Serial
    1005, 1011, 1013, 1014, 1016, 1017, 1018, 1019, 1020, 1021, 1024, 1032, 1036, 1039, 1041, 1043, 1044, 1047, 1049, 1050, 1051, 1052, 1053, 1059, 1063, 1066, 1067, 1068, 1069, 1070, 1071, 1075, 1096, 1101, 1102, 1103, 1104, 1105, 1111, 1112, 1113, 1115, 1129, 1130, 1133, 1134, 1135, 1136, 1137, 1138, 1139, 1140, 1146, 1147, 1148, 1149, 1150, 1151, 1152, 1166, 1167, 1168, 1181, 1182, 1183, 1184, 1216, 1217, 1218, 1219, 1220, 1231, 1232, 1233, 1234, 1235, 1245, 1246, 1247, 1248, 1254, 1255, 1261, 1262, 1263, 1264, 1270, 1271, 1272, 1273, 1274, 1285, 1286, 1287, 1288, 1289, 1295, 1296, 1297, 1298, 1299, 1305, 1306, 1307, 1308, 1309, 1312, 1313, 1314, 1315, 1321, 1332, 1333, 1334, 1340, 1341, 1342, 1344, 1350, 1352, 1353, 1354, 1357, 1358, 1379, 1380, 1383, 1389, 1390, 1391, 1392, 1393, 1399, 1400, 1401, 1402, 1403, 1404, 1405, 1406, 1408, 1414, 1415, 1416, 1418, 1421, 1422, 1424, 1425, 1426, 1427, 1428, 1429, 1430, 1431, 1432, 1433, 1439, 1440, 1441, 1442, 1443, 1450, 1451, 1452, 1453, 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2454, 2455, 2456, 2457, 2458, 2463, 2464, 2465, 2466, 2467, 2470, 2471, 2472, 2476, 2477, 2478, 2479, 2480, 2481, 2482, 2483, 2487, 2488, 2489, 2490, 2491, 2492, 2493, 2494, 2495, 2496, 2497, 2498, 2499, 2500, 2501, 2502, 2503, 2514, 2515, 2516, 2517, 2521, 2522, 2523, 2524, 2525, 2541, 2542, 2543, 2544, 2545, 2546, 2547, 2548, 2549, 2550, 2551, 2552, 2553, 2554, 2555, 2556, 2565, 2566, 2567, 2568, 2569, 2570, 2571, 2572, 2573, 2574, 2575, 2576, 2577, 2578, 2579, 2580, 2581, 2582, 2587, 2588, 2589, 2590, 2591, 2592, 2593, 2594, 2595, 2596, 2597, 2598, 2599, 2600, 2601, 2602, 2603, 2629, 2630, 2631, 2632, 2633, 2635, 2636, 2637, 2638, 2639, 2640, 2641, 2642, 2646, 2647, 2656, 2661, 2662, 2664, 2665, 2666, 2667, 2668, 2669, 2670, 2671, 2672, 2673, 2674, 2675, 2676, 2677, 2678, 2679, 2680, 2689, 2690, 2691, 2695, 2696, 2701, 2702, 2703, 2704, 2705, 2706, 2707, 2708, 2710, 2711, 2712, 2713, 2714, 2715, 2716, 2722, 2723, 2724, 2725, 2726, 2727, 2737, 2742, 2743, 2744, 2745, 2746, 2747, 2757, 2758, 2759, 2760, 2761, 2762, 2763, 2764, 2765, 2766, 2767, 2768, 2769, 2770, 2771, 2772, 2773, 2783, 2784, 2788, 2793, 2794, 2795, 2802, 2805, 2806, 2807, 2808, 2815, 2816, 2817, 2818, 2819, 2820, 2837, 2838, 2839, 2846, 2847, 2848, 2849, 2865, 2866, 2867, 2868, 2869, 2870, 2880, 2881, 2882, 2883, 2884, 2885, 2886, 2887, 2888, 2889, 2892, 2893, 2894, 2895, 2906, 2907, 2908, 2913, 2914, 2915, 2920, 2921, 2924, 2925, 2926, 2937, 2938, 2939, 2940, 2942, 2943, 2944, 2945, 2946, 2947, 2952, 2958, 2959, 2960, 2961, 2962, 2963, 2964, 2965, 2966, 2967, 2968, 2969, 2970, 2971, 2972, 2973, 2974, 2975, 2979, 2980, 2981, 2982, 2983, 2990, 2991, 2992, 2993, 2994, 2995, 2996, 2997, 2998, 2999, 3008, 3009, 3010, 3022, 3023, 3024, 3025, 3026, 3027, 3040, 3041, 3052, 3053, 3054, 3055, 3073, 3074, 3075, 3083, 3084, 3085, 3086, 3087, 3096, 3115, 3116, 3139, 3140, 3141, 3142, 3143, 3144, 3145, 3152, 3153, 3155, 3156, 3157, 3158, 3159, 3160, 3161, 3162, 3169, 3170, 3171, 3172, 3173, 3174, 3175, 3176, 3177, 3178, 3179, 3180, 3181, 3182, 3190, 3191, 3192, 3193, 3194, 3195, 3196, 3214, 3215, 3216, 3217, 3218, 3219, 3220, 3225, 3226, 3227, 3228, 3232, 3238, 3239, 3240, 3241, 3242, 3243, 3244, 3245, 3248, 3249, 3264, 3265, 3266, 3267, 3268, 3287, 3288, 3291, 3292, 3293, 3294, 3295, 3296, 3297, 3298, 3299, 3300, 3301, 3302, 3303, 3304, 3305, 3306, 3314, 3315, 3316, 3317, 3318, 3319, 3320, 3321, 3322, 3323, 3329, 3330, 3331, 3332, 3333, 3334, 3340, 3341, 3342, 3343, 3344, 3345, 3346, 3347, 3348, 3349, 3354, 3355, 3356, 3357, 3369, 3370, 3371, 3372, 3373, 3383, 3384, 3385, 3386, 3387, 3388, 3389, 3390, 3391, 3394, 3395, 3396, 3397, 3402, 3403, 3404, 3405, 3406, 3416, 3418, 3419, 3420, 3421, 3422, 3423, 3424, 3425, 3426, 3427, 3434, 3435, 3436, 3437, 3441, 3442, 3443, 3444, 3445, 3446, 3447, 3449, 3450, 3451, 3452, 3453, 3454, 3455, 3456, 3458, 3459, 3460, 3461, 3462, 3470, 3471, 3472, 3481, 3482, 3489, 3490, 3500, 3501, 3502, 3503, 3509, 3510, 3518, 3534, 3535, 3541, 3542, 3543, 3544, 3545, 3571, 3572, 3573, 3590, 3591, 3592, 3593, 3594, 3595, 3596, 3597, 3598, 3599, 3600, 3601, 3602, 3603, 3604, 3605, 3606, 3607, 3608, 3609, 3612, 3613, 3614, 3615, 3616, 3617, 3618, 3619, 3624, 3625, 3626, 3627, 3628, 3636, 3637, 3638, 3639, 3643, 3644, 3645, 3669, 3670, 3671, 3672, 3673, 3674, 3675, 3676, 3677, 3678, 3679, 3680, 3681, 3698, 3699, 3700, 3701, 3702, 3703, 3715, 3716, 3722, 3723, 3724, 3725, 3726, 3738, 3739, 3740, 3741, 3742, 3743, 3744, 3753, 3754, 3755, 3756, 3757, 3769, 3770, 3771, 3772, 3773, 3774, 3775, 3776, 3777, 3778, 3779, 3780, 3784, 3785, 3786, 3787, 3799, 3800, 3801, 3802, 3803, 3804, 3811, 3812, 3813, 3814, 3815, 3816, 3827, 3828, 3829, 3830, 3838, 3839, 3840, 3841, 3852, 3853, 3854, 3855, 3856, 3857, 3858, 3859, 3860, 3861, 3862, 3863, 3864, 3865, 3866, 3867, 3868, 3869, 3870, 3871, 3872, 3873, 3874, 3875, 3876, 3877, 3878, 3879, 3880, 3881, 3892, 3893, 3894, 3895, 3896, 3897, 3898, 3899, 3902, 3903, 3904, 3905, 3906, 3912, 3913, 3914, 3915, 3916, 3917, 3918, 3919, 3920, 3921, 3924, 3925, 3926, 3927, 3928, 3929, 3930, 3931, 3937, 3938, 3939, 3940, 3941, 3942, 3943, 3944, 3945, 3946, 3947, 3948, 3949, 3950, 3951, 3952, 3962, 3963, 3964, 3965, 3971, 3972, 3973, 3974, 3986, 3987, 3988, 3989, 3995, 3996, 3997, 3998, 4006, 4007, 4008, 4009, 4010, 4011, 4012, 4013, 4014, 4015, 4016, 4017, 4018, 4019, 4020, 4021, 4022, 4023, 4024, 4025, 4026, 4027, 4028, 4029, 4038, 4039, 4040, 4041, 4042, 4043, 4050, 4051, 4052, 4053, 4054, 4055, 4070, 4071, 4072, 4073, 4074, 4075, 4082, 4083, 4084, 4085, 4086, 4087, 4088, 4089, 4096, 4097, 4098, 4099, 4105, 4106, 4107, 4108, 4114, 4115, 4116, 4117, 4118, 4119, 4120, 4121, 4122, 4123, 4124, 4125, 4126, 4127, 4128, 4129, 4130, 4131, 4143, 4144, 4145, 4146, 4147, 4148, 4169, 4170, 4171, 4172, 4173, 4174, 4175, 4176, 4177, 4178, 4179, 4180, 4181, 4182, 4183, 4184, 4185, 4203, 4204, 4205, 4206, 4207, 4208, 4209, 4210, 4211, 4212, 4219, 4220, 4221, 4222, 4223, 4224, 4230, 4231, 4232, 4233, 4234, 4235, 4236, 4237, 4238, 4239, 4240, 4241, 4260, 4261, 4262, 4263, 4264, 4265, 4266, 4267, 4268, 4269, 4270, 4271, 4272, 4273, 4274, 4275, 4276, 4277, 4278, 4279, 4280, 4290, 4291, 4292, 4293, 4294, 4295, 4296, 4297, 4298, 4299, 4307, 4308, 4309, 4310, 4318, 4319, 4320, 4321, 4322, 4323, 4335, 4336, 4337, 4338, 4339, 4340, 4341, 4342, 4343, 4344, 4351 and 4352.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries of : Australia, Barbados, Belgium, Brazil, Columbia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatamala, Hong Kong, Honduras, Jordan, Japan, Libya, Mexico, Malaysia, Panama, PH, Saudi Arabia, Singapore, South Africa, Thailand, Trinidad, Taiwan and Uruguay, Germany, Saudia Arabia, Paraguay, South Korea, Dominican Republic, Phillipines, South Africa and UAE.
  • Product Description
    CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe, Catalog 500AVHCT, Terumo Cardiovascular Systems Corporations, Ann Arbor, MI. || The CDI 500 is indicated for use to display patient blood gas values during extracorporeal procedures.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation
Device Recall CDI 500 Blood Parameter Monitoring System
  • Model / Serial
    1559, 1560, 1561, 1562, 1563, 1663, 1664, 1665, 1666, 1722, 1723, 1724, 1725, 1727, 1754, 1755, 1757, 1758, 1776, 1795, 1951, 1952, 2016, 2112, 2190, 2273, 2274, 2322, 2355, 2356, 2389, 2390, 2391, 2393, 2394, 2397, 2634, 2700, 2801, 2804, 2860, 2890, 2891, 3011, 3012, 3013, 3125, 3146, 3263, 3289, 3410, 3417, 3480, 3629, 3630, 3631, 3646, 3647 and 3661.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries of : Australia, Barbados, Belgium, Brazil, Columbia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatamala, Hong Kong, Honduras, Jordan, Japan, Libya, Mexico, Malaysia, Panama, PH, Saudi Arabia, Singapore, South Africa, Thailand, Trinidad, Taiwan and Uruguay, Germany, Saudia Arabia, Paraguay, South Korea, Dominican Republic, Phillipines, South Africa and UAE.
  • Product Description
    CDI Blood Parameter Monitoring System 500 with Arterial Blood parameter module Catalog number 500A , Terumo Cardiovascular Systems Corporations, Ann Arbor, MI. || The CDI 500 is indicated for use to display patient blood gas values during extracorporeal procedures. The CDI 500 system is a stand alone systems that is used during extracorporeal procedures to continuously monitor the blood in the extracorporeal circuit, providing ongoing information about the blood parameters.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation
Device Recall CDI 500 Blood Parameter Monitoring System
  • Model / Serial
    1564, 1565 and 1566.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries of : Australia, Barbados, Belgium, Brazil, Columbia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatamala, Hong Kong, Honduras, Jordan, Japan, Libya, Mexico, Malaysia, Panama, PH, Saudi Arabia, Singapore, South Africa, Thailand, Trinidad, Taiwan and Uruguay, Germany, Saudia Arabia, Paraguay, South Korea, Dominican Republic, Phillipines, South Africa and UAE.
  • Product Description
    CDI Blood Parameter Monitoring System 500 with Venous Blood parameter module Catalog number 500V , Terumo Cardiovascular Systems Corporations, Ann Arbor, MI. || The CDI 500 is indicated for use to display patient blood gas values during extracorporeal procedures. The CDI 500 system is a stand alone systems that is used during extracorporeal procedures to continuously monitor the blood in the extracorporeal circuit, providing ongoing information about the blood parameters.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation