BEUDAMED
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    Artis Q.zen Biplane, Model No. 10848355 Artis Q.zen Ceiling, Model No. 10848354 Artis Q.zen Floor, Model No. 10848353 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·March 25, 2020

    Alaris PC units, Model No. 8015. Infusion pump.

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code FRN·March 12, 2015

    Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System.

    FDA Recall
    Terminated ·Carefusion Corporation·Product code FRN·March 6, 2013

    SmartSite Low Sorbing Infusion Set, Model No. 10015862 The SmartSite Infusion Sets are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. The set is comprised of components commonly found on intravascular administration sets and extension sets. It includes a SmartSite bag access port, a non-vented drip chamber, roller clamp, infusion pump segment, a male luer, and low sorbing tubing.

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code FPA·January 13, 2015

    SmartSite Extension Set, Model No. 20029E. Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code FPA·October 9, 2015

    Alaris PC Unit, Model 8015

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code FRN·June 12, 2017

    Alaris EtCO2 Module, Model 8300. A capnograph that continuously monitors end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2), and respiratory rate (RR).

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code CCK·November 12, 2015

    CareFusion SmartSite Gravity Blood Set Model 42082E. Used to administer blood and blood products through a needle or catheter inserted into the patient's artery or vein.

    FDA Recall
    Terminated ·Carefusion 303 Inc 3750 Torrey View Ct San Diego CA 92130-2622·Product code FPA·December 20, 2012

    Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System

    FDA Recall
    Terminated ·Carefusion Corporation·Product code FRN·March 6, 2013

    Trifurcated Extension Set, model no. ME 1224. Trifurcated Extension Set, model no. MP 9230.

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code FPA·January 16, 2014

    Alaris PC Unit, Infusion Pump Model 8000, Part No. TC10005092

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code FRO·February 12, 2016

    Alaris PC unit, Model 8015 The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System.

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code FRN·March 24, 2016

    SmartSite Low Sorbing Infusion Set with Texium Close Male Luer, Model No. 24301-0007T The SmartSite Low Sorbing Infusion Sets with Texium Male Luer are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code FPA·November 8, 2013

    Alaris PC unit model 8015, Infusion pump. software version 9.17 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The software is embedded in the Alaris PC unit.

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code FRN·May 13, 2015

    Alaris PC unit model 8000 and 8015 with Alaris PCA module model 8120 and Auto ID barcode scanner model 8600. Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The Alaris PCA (Patient Controlled Analgesia) pump is one of the modules offer under the Alaris System. The Auto ID is a barcode scanner.

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code FRN·December 5, 2013

    Alaris System PC unit, model no. 8000 and 8015. The central programming, monitoring and power supply component for the Alaris infusion pump System.

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code FRN·November 1, 2016

    Alaris Syringe Module Model 8110 with software version 9.15 The Alaris Syringe Pump module is part of the Alaris System. The syringe pump delivers fluids in a manner similar to current syringe pumps on the market. Up to four Alaris Syringe pump modules can be connected to the Alaris PC unit which is the central programming, monitoring and power supply component for the Alaris System. The syringe pump uses standard, single-use administration sets and syringes with luer-lock connectors.

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code FRN·August 8, 2016

    Alaris Pump Module model 8100. Subsequent product code: FPA The Pump module is intended for facilities that utilize infusion for the delivery of fluids, medications, blood, and blood products using continuous or intermittent delivery through clinically acceptable routes of administration; such as, intravenous (IV), intra-arterial (IA),subcutaneous, epidural, enteral, or irrigation of fluid spaces. The Pump module is indicated for use on adults, pediatrics, and neonates.

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code FRN·June 29, 2012

    Alaris PC unit model 8015 Product Usage: The device is labeled for prescription use only.

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code FRN·May 25, 2012

    SmartSite Needleless Connector, Model No. 2000E The SmartSite Needleless Connectors are sterile, individually packaged connectors. The connectors are used to administer fluid and medications. The needle free connector allows the user to add medication into the primary line without the use of a needle.

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code FPA·January 22, 2014