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Recall Observatory FDA recall evidence

Device product

Vacuum Unit for CATSmart Vacuum Pump. Fresenius CATSmart (Continuous Autotransfusion System) is indicated for the processing of blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion.

Z-1059-2019

February 11, 2019

Class II

Product summary

Firm
Fenwal Inc
Event
Event 82194
Status
Terminated
Classification
Class II
Quantity
198 devices
Official record key
device-enforcement:Z-1059-2019

Official wording

Reason: The optional Vacuum Unit may stop working and display the failure message "Failure vacuum unit" during use.

Code information: Material Number 9005851; Serial Numbers: 5VTA0180, 5VTA0183, 5VTA0194, 5VTA0195, 5VTA0196, 5VTA0197, 5VTA0198, 5VTA0199, 5VTA0200, 5VTA0201, 5VTA0202, 5VTA0203, 5VTA0204, 5VTA0205, 5VTA0206, 5VTA0234, 5VTA0235, 5VTA0236, 5VTA0237, 5VTA0238, 5VTA0239, 5VTA0240, 5VTA0241, 5VTA0242, 5VTA0243, 5VTA0244, 5VTA0245, 5VTA0246, 5VTA0247, 5VTA0248, 5VTA0249, 5VTA0250, 5VTA0251, 5VTA0252, 5VTA0253, 5VTA0254, 5VTA0255, 5VTA0256, 6VTA0257, 6VTA0258, 6VTA0259, 6VTA0260, 6VTA0261, 6VTA0262, 6VTA0263, 6VTA0264, 6VTA0265, 6VTA0266, 6VTA0289, 6VTA0295, 6VTA0296, 6VTA0297, 6VTA0298, 6VTA0299, 6VTA0300, 6VTA0301, 6VTA0302, 6VTA0303, 6VTA0304, 6VTA0305, 6VTA0337, 6VTA0338, 6VTA0339, 6VTA0340, 6VTA0341, 6VTA0342, 6VTA0343, 6VTA0344, 6VTA0430, 6VTA0431, 6VTA0432, 6VTA0433, 6VTA0434, 6VTA0435, 6VTA0436, 6VTA0437, 6VTA0438, 6VTA0439, 6VTA0440, 6VTA0441, 6VTA0442, 6VTA0443, 6VTA0444, 6VTA0445, 6VTA0450, 6VTA0451, 6VTA0452, 6VTA0453, 6VTA0454, 6VTA0455, 6VTA0456, 6VTA0457, 7VTA0458, 7VTA0459, 7VTA0460, 7VTA0461, 7VTA0463, 7VTA0464, 7VTA0465, 7VTA0466, 7VTA0467, 7VTA0468, 7VTA0469, 7VTA0470, 7VTA0471, 7VTA0472, 7VTA0473, 7VTA0474, 7VTA0475, 7VTA0476, 7VTA0477, 7VTA0478, 7VTA0479, 7VTA0480, 7VTA0481, 7VTA0482, 7VTA0483, 7VTA0484, 7VTA0485, 7VTA0486, 7VTA0487, 7VTA0488, 7VTA0489, 7VTA0490, 7VTA0491, 7VTA0492, 7VTA0493, 7VTA0494, 7VTA0495, 7VTA0496, 7VTA0497, 7VTA0525, 7VTA0526, 7VTA0527, 7VTA0528, 7VTA0529, 7VTA0530, 7VTA0531, 7VTA0532, 7VTA0533, 7VTA0534, 7VTA0535, 7VTA0536, 7VTA0537, 7VTA0538, 7VTA0539, 7VTA0540, 7VTA0541, 7VTA0542, 7VTA0543, 7VTA0544, 7VTA0545, 7VTA0553, 7VTA0554, 7VTA0555, 7VTA0558, 7VTA0559, 7VTA0560, 7VTA0575, 7VTA0582, 7VTA0583, 7VTA0584, 7VTA0585, 7VTA0586, 7VTA0587, 7VTA0588, 7VTA0589, 7VTA0590, 7VTA0591, 7VTA0592, 7VTA0593, 7VTA0594, 7VTA0595, 7VTA0596, 7VTA0597, 7VTA0598, 7VTA0599, 7VTA0606, 7VTA0607, 7VTA0608, 7VTA0609, 7VTA0610, 7VTA0611, 7VTA0612, 7VTA0613, 7VTA0614, 7VTA0616, 7VTA0617, 7VTA0618, 7VTA0620, 7VTA0672, 7VTA0673, 7VTA0674, 7VTA0675, 7VTA0676, 7VTA0677, 7VTA0678, 7VTA0679, 7VTA0680, 7VTA0681, 7VTA0683, 7VTA0684, 7VTA0685, 7VTA0686, 7VTA0687, 7VTA0688, 7VTA0689, 7VTA0690, 7VTA0691, 7VTA0692, 7VTA0693, 7VTA0694, 7VTA0695, 7VTA0696, 7VTA0697, 7VTA0698, 7VTA0699, 7VTA0700, 7VTA0701, 7VTA0702, 7VTA0708, 7VTA0709, 7VTA0710, 7VTA0711, 7VTA0712, 7VTA0713, 7VTA0714, 7VTA0715, 7VTA0716, 7VTA0717, 7VTA0718, 7VTA0719, 7VTA0720, 7VTA0721, 7VTA0722, 7VTA0723, 7VTA0724, 7VTA0725, 7VTA0729, 7VTA0759, 7VTA0760, 7VTA0761, 7VTA0762, 7VTA0763, 7VTA0764, 7VTA0765, 7VTA0766, 7VTA0767, 7VTA0768, 7VTA0769, 7VTA0770, 7VTA0771, 7VTA0772, 7VTA0773, 7VTA0774, 7VTA0775, 7VTA0776, 7VTA0777, 7VTA0778, 7VTA0779, 7VTA0780, 7VTA0781, 7VTA0806, 7VTA0807, 7VTA0858, 7VTA0859, 7VTA0860, 7VTA0861, 7VTA0862, 7VTA0863, 7VTA0864, 7VTA0865, 7VTA0866, 7VTA0867, 7VTA0868, 7VTA0869, 7VTA0870, 7VTA0871, 7VTA0872, 7VTA0873, 7VTA0874, 7VTA0875, 7VTA0876, 7VTA0877, 7VTA0878, 7VTA0879, 7VTA0880, 7VTA0881, 7VTA0898, 7VTA0901, 7VTA0902, 7VTA0903, 7VTA0904, 7VTA0905, 7VTA0906, 7VTA0907, 8VTA0908, 8VTA0909, 8VTA0910, 8VTA0911, 8VTA0912, 8VTA0913, 8VTA0914, 8VTA0915, 8VTA0916, 8VTA0917, 8VTA0918, 8VTA0919, 8VTA0920, 8VTA0921, 8VTA0922, 8VTA0923, 8VTA0924, 8VTA0925, 8VTA0926, 8VTA0937, 8VTA0938, 8VTA0939, 8VTA0940, 8VTA0941, 8VTA0942, 8VTA0943, 8VTA0944, 8VTA0945, 8VTA0946, 8VTA0947, 8VTA0948, 8VTA0949, 8VTA0950, 8VTA0951, 8VTA0952, 8VTA0953, 8VTA0954, 8VTA0955, 8VTA0956, 8VTA0957.

Distribution pattern: US Nationwide Distribution to states of: AZ, CA, FL, HI, ID, IL, IN, MD, MI, MN, MO, NC, ND, NE, NJ, NV, NY, OK, OR, PA, TN, TX, VA and PR; and Internationally to Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The optional Vacuum Unit may stop working and display the failure message "Failure vacuum unit" during use.