FDA Medical Device · Z-1209-2019

Fresenius Kabi CATSmart device (Continuous autotransfusion System). Labeled as the following kits: 1. AT-1 sets and kits (9005104 AT-1 Autotransfusion set, 9108504 ATF 120 Fast Start Kit, and 9108494 ATF 40 Fast Start Kits); 2. AT-3 Autotransfusion sets and kits (Part 9005444 AT-3 set, 9104444 ATF-120 Fast Start Kits (AT-3), or 9108444 ATF-40 Fast Start Kits AT-3) Product Usage: The Fresenius Kabi CATSmart device (Continuous auto transfusion System) is indicated for the processing of autologous shed blood collected interaoperatively and postoperatively to obtain washed packed red blood cells for reinfusion. The CATSmart Auto transfusion System is designed to reduce the need for allogeneic blood transfusion by re-infusing a patient s own lost blood during surgery. The set is used as a disposable component of the autotransfusion system during surgery and/or treatment of trauma to remove waste and improve the safety of autologous re-infused blood (auto transfusion). This is a single-use device.

Class II · Terminated

Based on internal investigations, Fresenius Kabi has identified a multifaceted set of events involving the CATSmart Systems, including the device, software, and disposable which may result in the centrifuge tubing line making contact with the washing chamber. The contact may result in excessive wear of the centrifuge tubing or in extreme cases a puncture of the tubing.

Affected lots / codes — check yours against thisProduct Code: 9005901; Lot Numbers beginning with GM or H. Serial Numbers: 6CTA0209, 6CTA0210, 6CTA0211, 6CTA0212, 6CTA0213, 6CTA0214, 6CTA0215, 6CTA0216, 6CTA0217, 6CTA0218, 6CTA0219, 6CTA0221, 6CTA0222, 6CTA0223, 6CTA0224, 6CTA0225, 6CTA0226, 6CTA0227, 6CTA0228, 6CTA0260, 6CTA0261, 6CTA0262, 6CTA0263, 6CTA0264, 6CTA0265, 6CTA0266, 6CTA0267, 6CTA0268, 6CTA0269, 6CTA0300, 6CTA0301, 6CTA0302, 6CTA0303, 6CTA0304, 6CTA0305, 6CTA0306, 6CTA0307, 6CTA0308, 6CTA0309, 7CTA0328, 7CTA0329, 7CTA0330, 7CTA0331, 7CTA0332, 7CTA0334, 7CTA0335, 7CTA0336, 7CTA0337, 7CTA0358, 7CTA0359, 7CTA0360, 7CTA0361, 7CTA0362, 7CTA0363, 7CTA0364, 7CTA0365, 7CTA0366, 7CTA0367, 7CTA0368, 7CTA0369, 7CTA0370, 7CTA0371, 7CTA0372, 7CTA0373, 7CTA0374, 7CTA0375, 7CTA0376, 7CTA0377, 7CTA0378, 7CTA0379, 7CTA0380, 7CTA0381, 7CTA0392, 7CTA0393, 7CTA0394, 7CTA0395, 7CTA0396, 7CTA0397, 7CTA0398, 7CTA0399, 7CTA0401, 7CTA0402, 7CTA0403, 7CTA0404, 7CTA0405, 7CTA0406, 7CTA0409, 7CTA0410, 7CTA0411, 7CTA0412, 7CTA0413, 7CTA0414, 7CTA0433, 7CTA0434, 7CTA0435, 7CTA0436, 7CTA0437, 7CTA0438, 7CTA0439, 7CTA0440, 7CTA0472, 7CTA0473, 7CTA0474, 7CTA0475, 7CTA0476, 7CTA0477, 7CTA0478, 7CTA0479, 7CTA0480, 7CTA0481, 7CTA0482, 7CTA0483, 7CTA0484, 7CTA0485, 7CTA0486, 7CTA0487, 7CTA0488, 7CTA0489, 7CTA0509, 7CTA0510, 7CTA0511, 7CTA0512, 7CTA0513, 7CTA0514, 7CTA0515, 7CTA0516, 7CTA0517, 7CTA0518, 7CTA0519, 7CTA0520, 7CTA0521, 7CTA0522, 7CTA0523, 7CTA0548, 7CTA0549, 7CTA0550, 7CTA0551, 7CTA0552, 7CTA0553, 7CTA0554, 7CTA0556, 7CTA0557, 7CTA0558, 7CTA0580, 7CTA0581, 7CTA0582, 7CTA0583, 7CTA0584, 7CTA0585, 7CTA0586, 7CTA0587, 7CTA0588, 7CTA0589, 7CTA0590, 7CTA0591, 7CTA0647, 7CTA0648, 7CTA0649, 7CTA0650, 7CTA0651, 7CTA0652, 7CTA0653, 7CTA0654, 7CTA0655, 7CTA0656, 7CTA0657, 7CTA0658, 7CTA0659, 7CTA0660, 7CTA0661, 7CTA0662, 7CTA0663, 7CTA0664, 7CTA0665, 7CTA0666, 7CTA0687, 7CTA0688, 7CTA0689, 7CTA0690, 7CTA0691, 7CTA0692, 7CTA0696, 7CTA0697, 7CTA0698, 7CTA0699, 7CTA0700, 7CTA0701, 7CTA0702, 7CTA0715, 7CTA0716, 7CTA0717, 7CTA0719, 7CTA0720, 7CTA0721, 7CTA0722, 7CTA0723, 7CTA0724, 7CTA0735, 7CTA0736, 7CTA0737, 7CTA0738, 7CTA0739, 7CTA0740, 8CTA0741, 8CTA0742, 8CTA0748, 8CTA0749, 8CTA0754, 8CTA0911, 8CTA0912, 8CTA0913, 8CTA0914, 8CTA0915, 8CTA0916, 8CTA0917, 8CTA0918, 8CTA0919, 8CTA0920, 8CTA0921, 8CTA0922, 8CTA0923, 8CTA0924, 8CTA0925, 8CTA0926, 8CTA0927, 8CTA0928, 8CTA0929, 8CTA0930, 8CTA0931, 8CTA0932, 8CTA0933, 8CTA0934, 8CTA0935, 8CTA0936, 8CTA0937, 8CTA0938, 8CTA0939, 8CTA0940, 8CTA0942, 8CTA0943, 8CTA0944, 8CTA0945, 8CTA0946, 8CTA0947, 8CTA0948, 8CTA0949, 8CTA0950, 8CTA0951, 8CTA0952, 8CTA0953, 8CTA0954, 8CTA0955, 8CTA0956, 8CTA0957, 8CTA0958, 8CTA0959, 8CTA0960, 8CTA0961, 8CTA0962, 8CTA0963, 8CTA0964, 8CTA0965, 8CTA0966, 8CTA0967, 8CTA0968, 8CTA0969, 8CTA0970, 8CTA0971, 8CTA0972, 8CTA0973, 8CTA0974, 8CTA0975, 8CTA0976, 8CTA0977, 8CTA0978, 8CTA0979, 8CTA0980, 8CTA0981, 8CTA0982, 8CTA0983, 8CTA0984, 8CTA0985, 8CTA0986, 8CTA0987, 8CTA0988, 8CTA0989, 8CTA0990, 8CTA0991, 8CTA0992, 8CTA0993, 8CTA0994, 8CTA0996, 8CTA0997, 8CTA0998, 8CTA0999, 8CTA1000, 8CTA1001, 8CTA1002, 8CTA1003, 8CTA1004, 8CTA1005, 8CTA1006, 8CTA1007, 8CTA1008, 8CTA1009, 8CTA1010, 8CTA1011, 8CTA1032, 8CTA1033, 8CTA1037, 8CTA1039, 8CTA1040, 8CTA1041, 8CTA1042, 8CTA1053, 8CTA1057, 8CTA1056, 8CTA1055, 8CTA1054, 8CTA1051, 6CTA0220, 8CTA1050, 8CTA1049, 8CTA1048, 8CTA1047, 8CTA1046, 8CTA1045, 7CTA0333, 8CTA1044, 8CTA1043, 8CTA0995, 8CTA1024, 8CTA1025, 8CTA1026, 8CTA1027, 8CTA1028, 8CTA1029, 8CTA1030, 8CTA1031, 8CTA1034, 8CTA1035, 8CTA1036, 8CTA1038

Recalling firm: Fenwal Inc, Lake Zurich, IL
Classification: Class II (temporary or reversible harm possible)
Status: Terminated
Quantity: 342 devices
Distribution: Worldwide distribution - US nationwide in the states of AL, AZ, CA, CO, FL, GA, HI, ID, IL, IN, LA, MA, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, and PR, and country of Canada.
Recall initiated: March 5, 2019
Classified: April 23, 2019
Terminated: October 5, 2020
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1209-2019%22

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