Device Recall CDI 500 Blood Parameter Monitoring System

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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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.

Cardiovascular Devices

2

No

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.

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.

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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2539, 2540, 2557, 2558, 2559, 2560, 2561, 2563, 2564, 2583, 2584, 2585, 2586, 2604, 2605, 2606, 2607, 2608, 2611, 2612, 2613, 2614, 2615, 2616, 2618, 2619, 2620, 2621, 2622, 2623, 2624, 2625, 2626, 2627, 2628, 2643, 2644, 2645, 2648, 2649, 2650, 2651, 2652, 2653, 2654, 2655, 2657, 2658, 2659, 2660, 2663, 2681, 2682, 2683, 2684, 2685, 2686, 2687, 2688, 2692, 2693, 2694, 2697, 2698, 2699, 2709, 2717, 2718, 2719, 2720, 2721, 2728, 2729, 2730, 2731, 2732, 2733, 2734, 2735, 2736, 2738, 2739, 2740, 2741, 2748, 2749, 2750, 2751, 2752, 2753, 2754, 2755, 2756, 2774, 2775, 2776, 2777, 2778, 2779, 2780, 2781, 2785, 2786, 2787, 2789, 2790, 2792, 2796, 2797, 2798, 2799, 2803, 2809, 2810, 2811, 2812, 2813, 2814, 2821, 2822, 2823, 2824, 2825, 2826, 2827, 2828, 2829, 2830, 2831, 2832, 2833, 2834, 2835, 2836, 2840, 2841, 2842, 2843, 2844, 2845, 2850, 2851, 2852, 2853, 2854, 2855, 2856, 2857, 2858, 2859, 2861, 2862, 2863, 2864, 2871, 2872, 2873, 2874, 2875, 2876, 2877, 2878, 2879, 2896, 2897, 2898, 2899, 2900, 2903, 2904, 2905, 2909, 2910, 2911, 2912, 2916, 2917, 2918, 2919, 2922, 2923, 2927, 2928, 2929, 2930, 2931, 2932, 2933, 2934, 2935, 2936, 2941, 2948, 2949, 2950, 2951, 2953, 2954, 2955, 2956, 2957, 2976, 2977, 2978, 2984, 2985, 2986, 2987, 2988, 2989, 3000, 3001, 3002, 3003, 3004, 3005, 3006, 3007, 3014, 3015, 3016, 3017, 3018, 3019, 3020, 3021, 3028, 3029, 3030, 3031, 3032, 3033, 3034, 3035, 3036, 3037, 3038, 3039, 3042, 3043, 3044, 3045, 3046, 3047, 3048, 3049, 3050, 3056, 3057, 3058, 3059, 3060, 3061, 3062, 3063, 3064, 3065, 3066, 3067, 3068, 3069, 3070, 3071, 3072, 3076, 3077, 3078, 3079, 3080, 3081, 3082, 3088, 3089, 3090, 3091, 3092, 3093, 3094, 3095, 3097, 3098, 3099, 3100, 3101, 3102, 3103, 3104, 3105, 3106, 3107, 3109, 3110, 3111, 3112, 3113, 3114, 3117, 3118, 3119, 3120, 3121, 3122, 3123, 3124, 3126, 3127, 3128, 3129, 3130, 3136, 3137, 3138, 3147, 3148, 3149, 3150, 3151, 3154, 3163, 3164, 3165, 3166, 3167, 3168, 3183, 3184, 3185, 3186, 3187, 3188, 3189, 3197, 3198, 3199, 3200, 3201, 3202, 3203, 3204, 3205, 3206, 3207, 3208, 3209, 3210, 3211, 3212, 3213, 3221, 3222, 3223, 3224, 3229, 3230, 3231, 3233, 3234, 3235, 3236, 3237, 3246, 3247, 3250, 3251, 3252, 3253, 3254, 3255, 3256, 3257, 3258, 3259, 3260, 3269, 3270, 3271, 3273, 3274, 3275, 3276, 3277, 3278, 3279, 3280, 3281, 3282, 3283, 3284, 3285, 3286, 3290, 3307, 3308, 3309, 3310, 3311, 3312, 3313, 3324, 3325, 3326, 3327, 3328, 3335, 3336, 3337, 3339, 3350, 3351, 3352, 3353, 3358, 3359, 3360, 3361, 3362, 3363, 3364, 3365, 3366, 3367, 3368, 3374, 3375, 3376, 3377, 3378, 3379, 3380, 3381, 3382, 3392, 3393, 3398, 3399, 3400, 3401, 3407, 3408, 3409, 3411, 3412, 3413, 3414, 3415, 3428, 3429, 3430, 3431, 3432, 3433, 3438, 3439, 3440, 3448, 3457, 3463, 3464, 3465, 3466, 3467, 3468, 3473, 3474, 3475, 3476, 3477, 3478, 3479, 3483, 3484, 3485, 3486, 3487, 3488, 3491, 3492, 3493, 3494, 3495, 3496, 3497, 3498, 3499, 3504, 3505, 3506, 3507, 3508, 3511, 3512, 3513, 3514, 3515, 3516, 3517, 3519, 3520, 3521, 3522, 3523, 3524, 3525, 3526, 3527, 3528, 3529, 3530, 3531, 3532, 3533, 3536, 3537, 3538, 3539, 3540, 3546, 3547, 3548, 3549, 3550, 3551, 3552, 3553, 3554, 3555, 3556, 3557, 3558, 3559, 3560, 3561, 3562, 3563, 3564, 3565, 3566, 3567, 3568, 3569, 3570, 3574, 3575, 3576, 3577, 3578, 3579, 3580, 3581, 3582, 3583, 3584, 3585, 3586, 3587, 3588, 3589, 3610, 3611, 3620, 3621, 3622, 3623, 3632, 3633, 3634, 3635, 3640, 3641, 3642, 3649, 3650, 3651, 3652, 3653, 3654, 3655, 3656, 3657, 3658, 3659, 3660, 3662, 3663, 3664, 3665, 3666, 3667, 3668, 3682, 3683, 3684, 3685, 3686, 3687, 3688, 3689, 3690, 3691, 3692, 3693, 3694, 3695, 3696, 3697, 3704, 3705, 3706, 3707, 3708, 3709, 3710, 3711, 3712, 3713, 3714, 3717, 3718, 3719, 3720, 3721, 3727, 3728, 3729, 3730, 3731, 3732, 3733, 3734, 3735, 3736, 3737, 3745, 3746, 3747, 3748, 3749, 3750, 3752, 3758, 3759, 3760, 3761, 3762, 3763, 3764, 3765, 3766, 3767, 3768, 3781, 3782, 3783, 3788, 3789, 3790, 3791, 3792, 3793, 3794, 3795, 3796, 3797, 3798, 3805, 3806, 3807, 3808, 3809, 3810, 3817, 3818, 3819, 3820, 3821, 3822, 3823, 3824, 3825, 3826, 3831, 3832, 3833, 3834, 3835, 3836, 3837, 3842, 3843, 3844, 3845, 3846, 3847, 3848, 3849, 3850, 3851, 3882, 3884, 3885, 3886, 3887, 3888, 3889, 3890, 3891, 3900, 3901, 3907, 3908, 3909, 3910, 3911, 3922, 3923, 3932, 3933, 3934, 3935, 3936, 3953, 3954, 3956, 3957, 3958, 3959, 3960, 3961, 3966, 3967, 3968, 3969, 3970, 3975, 3976, 3977, 3978, 3979, 3980, 3981, 3982, 3983, 3984, 3985, 3990, 3991, 3992, 3993, 3994, 3999, 4000, 4001, 4002, 4003, 4004, 4005, 4030, 4031, 4032, 4033, 4034, 4035, 4036, 4037, 4044, 4045, 4046, 4047, 4048, 4049, 4056, 4057, 4058, 4059, 4060, 4061, 4062, 4063, 4064, 4065, 4066, 4067, 4068, 4069, 4076, 4077, 4078, 4079, 4080, 4081, 4090, 4091, 4092, 4093, 4094, 4095, 4100, 4101, 4102, 4103, 4104, 4109, 4110, 4111, 4112, 4113, 4133, 4134, 4135, 4136, 4137, 4138, 4139, 4140, 4141, 4142, 4149, 4150, 4151, 4152, 4153, 4154, 4155, 4156, 4157, 4158, 4159, 4160, 4161, 4162, 4163, 4164, 4165, 4166, 4167, 4168, 4186, 4187, 4188, 4189, 4190, 4191, 4192, 4193, 4194, 4195, 4196, 4197, 4198, 4199, 4200, 4201, 4202, 4213, 4214, 4215, 4216, 4217, 4218, 4225, 4226, 4227, 4228, 4229, 4242, 4243, 4244, 4245, 4246, 4247, 4248, 4249, 4250, 4251, 4252, 4253, 4254, 4255, 4256, 4257, 4258, 4259, 4281, 4282, 4283, 4284, 4285, 4286, 4287, 4288, 4289, 4300, 4301, 4302, 4303, 4304, 4305, 4306, 4311, 4312, 4313, 4314, 4315, 4316, 4317, 4324, 4325, 4326, 4327, 4328, 4329, 4330, 4331, 4332, 4333, 4334, 4345, 4346, 4347, 4348, 4349, 4350, 4353, 4354, 4355, 4356, 4357, 4358, 4359, 4360, 4361, 4362, 4363, 4364, 4365, 4366, 4367, 4368, 4369, 4370 and 4371.

Cardiovascular Devices

2

No

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.

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.

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.

Cardiovascular Devices

2

No

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.

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.