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U.S. Department of Health and Human Services

Class 2 Device Recall CATSmart Autotransfusion

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  Class 2 Device Recall CATSmart Autotransfusion see related information
Date Initiated by Firm March 05, 2019
Create Date April 23, 2019
Recall Status1 Terminated 3 on October 05, 2020
Recall Number Z-1209-2019
Recall Event ID 82395
510(K)Number K160735  
Product Classification Apparatus, autotransfusion - Product Code CAC
Product 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.
Code Information Product 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/
Manufacturer		 Fenwal Inc
3 Corporate Dr Ste 300
Lake Zurich IL 60047-8930
For Additional Information Contact
800-937-5060
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Device Design
Action The initial distributor was notified by Fresenius Kabi on 03/05/2019, who provided their distribution list. Fresenius Kabi notified those customers on about 03/11/2019 via "IMPORTANT - CATSmart Software Upgrade and AT-1 sets used on CATSmart" letter. Customers were instructed that Fresenius Kabi will be implementing a software changed to improve priming acceleration. As an interim solution, Fresenius Kabi instructed that CATSmart users should switch to using 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). Additionally customers were requested to complete and return the Customer Reply Form. Customers will be contacted by a Fresenius Kabi service representative to schedule a service appointment for updating the software. They anticipate changing the software by October 1, 2019. Questions can be directed to Fresneius Kabi at 800-333-6925.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CAC and Original Applicant = FRESENIUS KABI AG
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