FDAClass IIApril 3, 2019

Vacuum Unit for CATSmart Vacuum Pump. Fresenius recall

Vacuum Unit for CATSmart Vacuum Pump. Fresenius CATSmart (Continuous Autotransfusion System) is indicated for the processing of blood collected…

Why was Vacuum Unit for CATSmart Vacuum Pump. Fresenius recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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.

Product
Vacuum Unit for CATSmart Vacuum Pump. Fresenius CATSmart (Continuous Autotransfusion System) is indicated for the processing of blood collected…
Recalling firm
Fenwal Inc
Quantity
198 devices
Distribution
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.
Recall date
April 3, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls