FDAFDA · Alimentos y medicamentos·N.º oficial Z-1400-2024
Hill-Rom PRO+ 36" MRS Surface, REF P7924A03, The pro+ mattress is intended for patient support and for the prevention and/or treatment of pressure injuries.
Publicado el 10 de abril de 2024 · Inicio del retiro: 5 de marzo de 2024
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Inconsistencies were identified with service records associated with corrections performed for a previous Medical Device Correction issued by Baxter (ref number: FA-2022-026). Your devices have been identified as potentially impacted by these service inconsistencies and therefore, Baxter will need to reassess the impacted mattresses to confirm they have been corrected as identified by the service order, and to confirm the correct serial numbers have been identified.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Baxter Healthcare Corporation
- Distribuidor
- US Nationwide distribution in the state of Colorado.
- Lote
- UDI/DI 00887761977884, Serial Numbers: W330BP6363, W333BP6439, W334BP6477, W334BP6535, W337BP6631, W341BP6675, X047BP7353, X049BP7431, W330BP6365, W333BP6440, W334BP6478, W334BP6536, W337BP6632, W341BP6676, X047BP7354, X049BP7432, W330BP6366, W333BP6442, W334BP6480, W334BP6537, W337BP6633, W341BP6678, X047BP7355, X049BP7433, W330BP6367, W333BP6445, W334BP6481, W337BP6565, W337BP6634, W341BP6679, X047BP7356, X063BP7505, W330BP6368, W333BP6446, W334BP6485, W337BP6566, W337BP6635, W341BP6681, X047BP7357, X063BP7506, W330BP6382, W333BP6447, W334BP6486, W337BP6567, W337BP6636, W341BP6683, X047BP7358, X063BP7507, W330BP6383, W333BP6448, W334BP6487, W337BP6568, W337BP6637, W341BP6684, X047BP7359, X063BP7508, W330BP6385, W333BP6450, W334BP6489, W337BP6569, W337BP6638, W341BP6687, X047BP7360, X063BP7509, W330BP6387, W333BP6451, W334BP6492, W337BP6570, W337BP6641, X046BP7330, X047BP7361, X063BP7510, W330BP6397, W333BP6452, W334BP6493, W337BP6571, W337BP6642, X046BP7331, X047BP7362, X063BP7511, W333BP6399, W333BP6453, W334BP6496, W337BP6572, W337BP6643, X046BP7332, X047BP7363, X063BP7512, W333BP6400, W333BP6455, W334BP6500, W337BP6573, W337BP6644, X046BP7333, X047BP7364, X063BP7513, W333BP6401, W333BP6456, W334BP6501, W337BP6574, W337BP6645, X046BP7334, X047BP7365, X063BP7514, W333BP6404, W333BP6457, W334BP6502, W337BP6575, W341BP6646, X046BP7335, X047BP7366, X066BP7516, W333BP6405, W333BP6458, W334BP6504, W337BP6577, W341BP6647, X046BP7336, X047BP7367, X066BP7517, W333BP6406, W333BP6459, W334BP6505, W337BP6578, W341BP6648, X046BP7337, X047BP7368, X066BP7518, W333BP6415, W333BP6460, W334BP6511, W337BP6579, W341BP6655, X046BP7338, X047BP7369, X066BP7519, W333BP6418, W333BP6461, W334BP6513, W337BP6583, W341BP6658, X046BP7339, X047BP7370, X066BP7520, W333BP6420, W333BP6463, W334BP6514, W337BP6614, W341BP6659, X046BP7340, X047BP7371, X066BP7521, W333BP6421, W333BP6465, W334BP6525, W337BP6615, W341BP6660, X047BP7342, X047BP7372, X066BP7522, W333BP6422, W333BP6466, W334BP6526, W337BP6621, W341BP6661, X047BP7343, X047BP7373, X066BP7523, W333BP6423, W333BP6467, W334BP6527, W337BP6622, W341BP6663, X047BP7344, X047BP7374, X066BP7524, W333BP6424, W334BP6468, W334BP6528, W337BP6623, W341BP6666, X047BP7345, X047BP7375, X066BP7525, W333BP6425, W334BP6469, W334BP6529, W337BP6624, W341BP6667, X047BP7346, X047BP7376, X066BP7526, W333BP6426, W334BP6470, W334BP6530, W337BP6625, W341BP6668, X047BP7347, X047BP7378, X066BP7527, W333BP6427, W334BP6471, W334BP6531, W337BP6626, W341BP6669, X047BP7348, X047BP7379, X066BP7531, W333BP6431, W334BP6473, W334BP6532, W337BP6628, W341BP6670, X047BP7350, X047BP7381, X066BP7532, W333BP6432, W334BP6475, W334BP6533, W337BP6629, W341BP6671, X047BP7351, X049BP7429, X066BP7533, W333BP6435, W334BP6476, W334BP6534, W337BP6630, W341BP6674, X047BP7352, X049BP7430, X066BP7540
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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