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 I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Fenwal Inc
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1209-2019
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