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FDAFDA · Alimentos y medicamentos·N.º oficial Z-1863-2021

GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860

Publicado el 30 de junio de 2021 · Inicio del retiro: 19 de mayo de 2021

Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

Reports received of NO measured below desired dose during transition between primary console and backup console since Software Version 2.2.3 was uploaded to consoles in the field.

Qué hacer

Voluntary: Firm initiated · E-Mail

Detalles del retiro

Fabricante
Vero Biotech, LLC
Distribuidor
Distributed nationwide to TX, MD, VA, GA, FL, KS, LA, MN, and NC
Lote
Model #: 601588-01; Serial #'s: G0803, G0807, G0808, G0814, G0149, G0157, G0183, G0191, G0195, G0198, G0202, G0560, G0600, G0693, G0729, G0734, G0772, G0775, G0138, G0147, G0155, G0159, G0172, G0185, G0203, G0209, G0282, G0344, G0385, G0398, G0408, G0415, G0569, G0601, G0756, G0323, G0358, G0379, G0383, G0386, G0405, G0334, G0399, G0413, G0463, G0158, G0174, G0285, G0305, G0466, G0719, G0135, G0194, G0205, G0281, G0362, G0407, G0573, G0574, G0578, G0579, G0582, G0583, G0587, G0590, G0591, G0594, G0596, G0597, G0598, G0603, G0609, G0611, G0680, G0708, G0110, G0111, G0131, G0137, G0140, G0176, G0207, G0212, G0232, G0237, G0246, G0251, G0253, G0262, G0263, G0266, G0280, G0449, G0453, G0608, G0642, G0644, G0663, G0688, G0712, G0717, G0739, G0745, G0747, G0762, G0764, G0765, G0793, G0125, G0129, G0133, G0169, G0181, G0257, G0292, G0645, G0804, G0180, G0293, G0311, G0322, G0338, G0341, G0342, G0353, G0480, G0499, G0506, G0519, G0521, G0522, G0565, G0681, G0735, G0738, G0748, G0754, G0760, G0770, G0773, G0773, G0782, G0223, G0227, G0235, G0236, G0347, G0352, G0355, G0359, G0378, G0382, G0175, G0273, G0476, G0562, G0792, G0162, G0163, G0189, G0607, G0143, G0160, G0164, G0214, G0215, G0283, G0284, G0296, G0298, G0303, G0313, G0315, G0319, G0329, G0333, G0335, G0370, G0375, G0495, G0509, G0510, G0511, G0550, G0571, G0588, G0589, G0593, G0646, G0672, G0689, G0723, G0724, G0725, G0736, G0744, G0771, G0778, G0795, G0204, G0218, G0269, G0272, G0343, G0580, G0193, G0294, G0300, G0302, G0308, G0465, G0518, G0567, G0190, G0278, G0279, g0286, G0297, G0374, G0393, G0728, G0307, G0309, G0312, G0318, G0320, G0406, G0434, G0643, G0229, G0230, G0231, G0240, G0460, G0469, G0488, G0489, G0493, G0496, G0500, G0501, G0599, G0605, G0610, G0647, G0648, G0650, G0651, G0653, G0654, G0655, G0656, G0658, G0661, G0667, G0668, G0670, G0671, G0677, G0678, G0686, G0691, G0694, G0697, G0702, G0707, G0713, G0715, G0716, G0718, G0726, G0730, G0733, G0741, G0755, G0806, G0813, G0818, G0261, G0270, G0274, G0275, G0094, G0363, G0369, G0430, G0435, G0440, G0444, G0452, G0475, G0487, G0490, G0508, G0537, G0549, G0234, G0380, G0389, G0402, G0409, G0483, G0497, G0576, G0584, G0585, G0277, G0346, G0390, G0423, G0443, G0445, G0447, G0451, G0454, G0455, G0457, G0458, G0459, G0461, G0464, G0467, G0474, G0479, G0481, G0486, G0492, G0504, G0512, G0515, G0516, G0517, G0520, G0524, G0527, G0528, G0529, G0531, G0532, G0533, G0536, G0539, G0542, G0545, G0546, G0547, G0551, G0552, G0553, G0554, G0557, G0558, G0559, G0561, G0570, G0581, G0602, G0710, G0743, G0749, G0752, G0768, G0787, G0289, G0371, G0357, G0372, G0391, G0701, G0186, G0327, G0337, G0568, G0604, G0675, G0679, G0682, G0692, G0700, G0703, G0396, G0397, G0228, G0245, G0288, G0387, G0414, G0418, G0420, G0437, G0439, G0535, G0572, G0211, G0268, G0365, G0544, G0592, G0252, G0349, G0606, G0192, G0417, G0485, G0507, G0523, G0563, G0146, G0166, G0304, G0306, G0314, G0332, G0339, G0403, G0422, G0424, G0428, G0429, G0431, G0432, G0436, G0450, G0473, G0491, G0426, G0427, G0301, G0425, G0706, G0720, G0722, G0727, G0789, G0797, G0799, G0805, G0665, G0684, G0696, G0714, G0740, G0796, G0367, G0595, G0721, G0731, G0732, G0109, G0124, G0136, G0139, G0331, G0468, G0566, G0810, G0816, G0381, G0767, G0779, G0790, G0737, G0763, G0766, G0774
Clasificación de riesgo
Class I
Área (FDA)
device
País
United States

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