BEUDAMED
    112 results · 61ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Terminated ×

    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

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code FRN·July 21, 2015

    Alaris System PC Unit Model 8015. modular infusion pump and monitoring system

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code FRN·June 30, 2020

    Alaris Pump Module Model 8100

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code FRN·June 30, 2020

    SmartSite Low Sorbing Infusion Set, Model# 10015048. Intravascular administration set.

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code FPA·August 30, 2013

    Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19; Central programming, monitoring and power supply component for the Alaris System.

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

    Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 11634567 and 8300ADXeN933

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code CCK·July 1, 2019

    SmartSite Add-On Bag Access Device, Model No. 10013365

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code FPA·November 17, 2016

    Alaris Pump Module Model 8100, a modular infusion pump and monitoring system

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code FRN·June 30, 2020

    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

    SmartSite Extension Set, Model No. 20029E, intravascular administration set.

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code FPA·March 19, 2014

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

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

    MaxGuard Extension Set, Model No. ME2064, MP9009C, MP9209, MP9254C The MaxGuard extension sets are used to administer fluids from a container to a patient s vascular system through a needle or catheter inserted into the patient s artery or vein. The extension sets may incorporate components that aid in the prevention of accidental needle sticks. The set s components are commonly found on intravascular administration sets and extension sets

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code FPA·February 20, 2017

    Alaris PC Unit, Model 8015

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

    Alaris SpO2 Module Model 8210 and Model 8220, a modular infusion pump and monitoring system

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code FRN·June 30, 2020

    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 Syringe Pump, Model 8110. The firm name on the label is CareFusion. The Alaris Syringe Pump module and Alaris PCA module are infusion pump modules for the Alaris System. The syringe pump and PCA pump delivers medication or fluids in a manner similar to current syringe pumps on the market. The modules are indicated for use on adults, pediatrics and neonates for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous, subcutaneous or epidural. The Alaris Syringe pump and PCA 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 and PCA pump uses standard, plastic piston syringes and single-use administration sets with luer-lock connectors.

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code FRN·November 17, 2017

    Alaris PCA Module Model 8120, a modular infusion pump and monitoring system

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code FRN·June 30, 2020

    Alaris System PC Unit Model 8000 modular infusion pump and monitoring system

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code FRN·June 30, 2020