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Terminated

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.

FDA Recall Z-1209-2019 · Posted None

Recalling FirmFenwal Inc
Recall StatusTerminated
Product CodeCAC
Date Initiated2019-03-05
Date Terminated2020-10-05
Product Quantity342 devices

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K160735CATSmartFresenius Kabi AG · 2016-09-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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