Impella Optical Controller with the below product descriptions and corresponding Product Codes. 1. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU. 2. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 3. Impella Optical Controller, Packaged, IN; Product Code: 0042-0010-IN. 4. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK. 5. Impella Optical Controller, Packaged, US; Product Code: 0042-0010-US.

Detalles del retiro

Fabricante

Abiomed, Inc.

Distribuidor

Domestic: Nationwide Distribution. International: United Arab Emirates, Austria, Australia, Belgium, Brunei Darussalam, Brazil, Canada, Switzerland, Chile, China, Colombia, Costa Rica, Cyprus, Czechia, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Croatia, Hungary, Ireland, Israel, India, Italy, Japan, Kuwait, Luxembourg, Mexico, Malaysia, Netherlands, Norway, New Zealand, Panama, Pakistan, Poland, Serbia, Saudi Arabia, Sweden, Singapore, Slovenia, Thailand, Taiwan;

Lote

1. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU; UDI-DI: 00813502010930; Serial Numbers: IC5130, IC5131; 2. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU; UDI-DI: 00813502010961; Serial Numbers: IC12955, IC12978, IC13013, IC13027, IC13042, IC13202, IC13223, IC13228, IC6947, IC6948, IC7625, IC7740, IC7741, IC8064, IC8065, IC8157, IC8158, IC8419, IC8727, IC7937, IC7940, IC9356, IC9363, IC9365, IC9369, IC9370, IC9371, IC9832, IC9833, IC5409, IC7794, IC7795, IC7796, IC7798, IC7799, IC7800, IC7945, IC7946, IC8069, IC8070, IC8263, IC8337, IC8341, IC8343, IC8441, IC8445, IC8447, IC8448, IC8449, IC8451, IC8861, IC9025, IC9028, IC9366, IC9799, IC8476A, IC9181A, IC13190, IC13205, IC9031, IC9094, IC9801, IC9865, IC9867, IC9973, IC7825, IC9095, IC8032, IC8126, IC8629, IC8630, IC8640, IC8641, IC9364, IC9368, IC9804, IC9805, IC9834, IC9835, IC8388, IC8751, IC9501, IC9972, IC10035, IC7629, IC7636, IC8164, IC8683, IC5592, IC6277, IC7046, IC7637, IC7638, IC7639, IC7640, IC7762, IC7763, IC7764, IC7765, IC8013, IC8057, IC8058, IC8128, IC8130, IC8131, IC8132, IC8387, IC8401, IC8402, IC8560, IC8621, IC8623, IC8748, IC8750, IC8752, IC8763, IC8814, IC9092, IC9432, IC11485, IC12328, IC12329, IC12332, IC12334, IC12346, IC13037, IC13038, IC8714, IC8775, IC8812, IC9005A, IC9006A, IC9008, IC9093, IC9096, IC9299, IC9783, IC9784, IC9961, IC7231, IC5037, IC5038, IC11162, IC11498, IC12326, IC12984, IC13239, IC13797, IC8488, IC8494, IC8503, IC8514, IC8588, IC8589, IC8642, IC8646, IC11691, IC4946, IC4947, IC4948, IC4949, IC4950, IC4951, IC4952, IC4953, IC4954, IC4955, IC4957, IC4958, IC4959, IC4960, IC4961, IC5039, IC5040, IC5041, IC5044, IC5045, IC5076, IC5077, IC5078, IC5079, IC5080, IC5081, IC5082, IC5084, IC5085, IC5096, IC5097, IC5098, IC5099, IC5100, IC5101, IC5102, IC5103, IC5104, IC5105, IC5106, IC5107, IC5108, IC5109, IC5110, IC5111, IC5112, IC5113, IC5114, IC5115, IC5126, IC5127, IC5128, IC5132, IC5133, IC5134, IC5135, IC5136, IC5137, IC5138, IC5139, IC5140, IC5141, IC5142, IC5143, IC5144, IC5145, IC5156, IC5157, IC5158, IC5159, IC5160, IC5161, IC5162, IC5163, IC5164, IC5233, IC5234, IC5235, IC5276, IC5277, IC5278, IC5279, IC5280, IC5281, IC5283, IC5284, IC5285, IC5350, IC5355, IC5376, IC5377, IC5378, IC5383, IC5396, IC5397, IC5399, IC5400, IC5401, IC5402, IC5403, IC5404, IC5407, IC5408, IC5410, IC5411, IC5412, IC5413, IC5414, IC5415, IC5526, IC5527, IC5528, IC5529, IC5530, IC5531, IC5532, IC5533, IC5534, IC5535, IC5566, IC5567, IC5568, IC5569, IC5570, IC5571, IC5572, IC5573, IC5574, IC5575, IC5576, IC5577, IC5578, IC5579, IC5581, IC5582, IC5583, IC5584, IC5585, IC5586, IC5587, IC5588, IC5589, IC5590, IC5591, IC5594, IC5595, IC5626, IC5627, IC5628, IC5629, IC5630, IC5631, IC5632, IC5633, IC5634, IC5635, IC5636, IC5638, IC5639, IC5640, IC5641, IC5642, IC5643, IC5644, IC5645, IC5666, IC5667, IC5668, IC5669, IC5671, IC5672, IC5801, IC5802, IC5803, IC5804, IC5805, IC5806, IC5807, IC5808, IC5809, IC5810, IC5811, IC5812, IC5813, IC5814, IC5896, IC5897, IC5898, IC5899, IC5900, IC5902, IC5903, IC5904, IC5905, IC5916, IC5918, IC5920, IC5921, IC5922, IC5923, IC5924, IC5925, IC5963, IC5964, IC5965, IC5966, IC5967, IC5968, IC6012, IC6013, IC6014, IC6015, IC6016, IC6017, IC6018, IC6019, IC6020, IC6021, IC6022, IC6023, IC6024, IC6025, IC6067, IC6068, IC6069, IC6070, IC6073, IC6074, IC6075, IC6116, IC6117, IC6120, IC6121, IC6122, IC6123, IC6124, IC6166, IC6167, IC6168, IC6169, IC6171, IC6172, IC6173, IC6174, IC6175, IC6226, IC6229, IC6230, IC6231, IC6232, IC6234, IC6235, IC6256, IC6257, IC6258, IC6259, IC6260, IC6265, IC6276, IC6278, IC6279, IC6280, IC6281, IC6282, IC6283, IC6297, IC6298, IC6299, IC6302, IC6303, IC6304, IC6305, IC6336, IC6337, IC6338, IC6339, IC6340, IC6341, IC6342, IC6343, IC6344, IC6345, IC6376, IC6377, IC6378, IC6379, IC6383, IC6384, IC6416, IC6417, IC6418, IC6421, IC6422, IC6460, IC6461, IC6462, IC6463, IC6465, IC6698, IC6703, IC6758, IC6776, IC6777, IC6779, IC6780, IC6781, IC6784, IC6785, IC67

Clasificación de riesgo

Class I

Área (FDA)

device

País

United States