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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