Z-1059-2019 Class II Terminated
FDA device recall Z-1059-2019 was initiated by Fenwal Inc on February 11, 2019 and is designated Class II. Reason for recall: The optional Vacuum Unit may stop working and display the failure message "Failure vacuum unit" during use. The recall status is terminated (terminated June 23, 2020). Affected quantity: 198 devices.
Recall Details
- Product Type
- Devices
- Report Date
- April 3, 2019
- Initiation Date
- February 11, 2019
- Termination Date
- June 23, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 198 devices
Product Description
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.
Reason for Recall
The optional Vacuum Unit may stop working and display the failure message "Failure vacuum unit" during use.
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.
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.