Reported May 1, 2019 · Terminated
Fresenius Kabi CATSmart device (Continuous autotransfusion System). Labeled as the following kits: 1. AT-1 sets and…
Fenwal Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fenwal Inc · 3 Corporate Dr Ste 300 · Lake Zurich, IL · 60047-8930
Is this the product you have?
- Fresenius Kabi CATSmart device (Continuous autotransfusion System)
- Labeled as the following kits1. 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 UsageThe 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
- Lot codes and dates
- Product Code9005901; Lot Numbers beginning with GM or H
- Serial Numbers
343 of 343 codes
6CTA02096CTA02106CTA02116CTA02126CTA02136CTA02146CTA02156CTA02166CTA02176CTA02186CTA02196CTA02216CTA02226CTA02236CTA02246CTA02256CTA02266CTA02276CTA02286CTA02606CTA02616CTA02626CTA02636CTA02646CTA02656CTA02666CTA02676CTA02686CTA02696CTA03006CTA03016CTA03026CTA03036CTA03046CTA03056CTA03066CTA03076CTA03086CTA03097CTA03287CTA03297CTA03307CTA03317CTA03327CTA03347CTA03357CTA03367CTA03377CTA03587CTA03597CTA03607CTA03617CTA03627CTA03637CTA03647CTA03657CTA03667CTA03677CTA03687CTA0369
- Amount recalled
- 342 devices
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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