Fresenius Kabi CATSmart device — Class II medical device recall Z-1209-2019
Terminated recall by Fenwal Inc, reported 2019-05-01, distributed nationwide. Based on internal investigations, Fresenius Kabi has identified a multifaceted set of events involving the CAT
| Recall number | Z-1209-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fenwal Inc, Lake Zurich, IL, United States |
| Recall initiated | 2019-03-05 |
| Classified | 2019-04-23 |
| Reported by FDA | 2019-05-01 |
| Terminated | 2020-10-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 342 devices |
| Reason classes | software |
| Serial numbers | 6CTA0209, 6CTA0210, 6CTA0211, 6CTA0212, 6CTA0213, 6CTA0214, 6CTA0215, 6CTA0216, 6CTA0217, 6CTA0218, 6CTA0219, 6CTA0220, 6CTA0221, 6CTA0222, 6CTA0223, 6CTA0224, 6CTA0225, 6CTA0226, 6CTA0227, 6CTA0228, 6CTA0260, 6CTA0261, 6CTA0262, 6CTA0263, 6CTA0264 and 318 more |
| Model numbers | 9005444, 9104444, AT-3, ATF-120 |
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.
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.