Z-1209-2019Class II

Fresenius Kabi CATSmart device (Continuous autotransfusion System). Labeled as the following kits: 1. AT-1...

Name: Z-1209-2019 Fresenius Kabi CATSmart device (Continuous autotransfusion System). Labeled as the following kits: 1. AT-1...
Creator: Fenwal Inc
Published: 2019-03-05
License: https://open.fda.gov/license/

Fenwal Inc / initiated 2019-03-05 / Terminated / root cause: design

FDA source

Fenwal Inc began a recall of Fresenius Kabi CATSmart device (Continuous autotransfusion System). Labeled as the following kits: 1. AT-1 sets and kits (9005104 AT-1 Autotransfusion set... on 2019-03-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1209-2019
Classification: Class II
Status: Terminated
Initiated: 2019-03-05
Posted: 2019-04-23
Terminated: 2020-10-05
Recalling firm: Fenwal Inc
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.
Product code: CAC Apparatus, Autotransfusion
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.
Root cause tag: design
FDA root cause: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1209-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1209-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-01	2019-04-23

Product code CAC

K160735Class IICATSmartFresenius Kabi AG / cleared 2016-09-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)