BEUDAMED
    153 results · 24ms · Sources: EU EUDAMED, US FDA

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    Universal Chuck-The Universal Chuck is an Instrument Handle provided as an alternative instrument available for use in the TN-ADVANCED" Tibial Nailing System (TNA), TFN-ADVANCED" Proximal Femoral Nailing System (TFNA), RFN-ADVANCED" Retrograde Femoral Nailing System (RFNA), FRN-ADVANCED" Femoral Recon Nailing System (FRNA), and Flexible Monobloc Reamers. Instrument Handles are intended for holding instruments for manipulation during orthopedic surgery. Product No.: 03.043.001

    FDA Recall
    Open, Classified ·Synthes (USA) Products LLC·Product code LXH·December 22, 2021

    Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and blood products to a patient under the direction or supervision of physician or other certified health care professional Model: Z-800WF

    FDA Recall
    Open, Classified ·Zyno Medical LLC·Product code FRN·December 20, 2023

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Recall
    Open, Classified ·Smiths Medical ASD Inc.·Product code FRN·February 27, 2024

    Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Wireless Model/Catalog Number: 8713031U Software Version: 8713031U Product Description: Perfusor Space Syringe Pump, Infusion Pump, 1 each Component: N/A

    FDA Recall
    Open, Classified ·B Braun Medical Inc·Product code FRN·June 14, 2024

    Alaris Pump Module Model 8100 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data.

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

    BD Alaris System PC Unit Model 8100 (Pump Module) and Pump Module Door Assembly Replacement Kits (P/N 49000239, 49000346, 49000438, 49000439) infusion pump.

    FDA Recall
    Open, Classified ·CareFusion 303, Inc.·Product code FRN·August 4, 2020

    Alaris Pump Module, Model 8100, serviced/repaired by Infusion Pump Repair with an impacted bezel repair part

    FDA Recall
    Open, Classified ·Infusion Pump Repair·Product code FRN·March 26, 2021

    BD Alaris System; Alaris Syringe Module Model 8110; BD Alaris System; Alaris PCA Module Model 8120; BD Alaris System; Syringe/PCA Sizer Sensor Replacement Kit, P/N 122278652

    FDA Recall
    Open, Classified ·CareFusion 303, Inc.·Product code FRN·August 4, 2020

    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fluids.

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code FRN·November 23, 2020

    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) - Product Usage: intended to be used for the controlled administration of fluids.

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code FRN·November 23, 2020

    Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004

    FDA Recall
    Open, Classified ·Fresenius Kabi USA, LLC·Product code FRN·March 10, 2023

    ASM Replacement Battery, Component Number SUB0000594

    FDA Recall
    Open, Classified ·ICU Medical Inc·Product code FRN·March 22, 2023

    Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0.1 Part Number: LVP-SW-0004. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration.

    FDA Recall
    Open, Classified ·Fresenius Kabi USA, LLC·Product code FRN·April 22, 2022

    Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system

    FDA Recall
    Open, Classified ·CareFusion 303, Inc.·Product code FRN·August 15, 2024

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

    FDA Recall
    Open, Classified ·CareFusion 303, Inc.·Product code FRN·August 15, 2024

    Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system

    FDA Recall
    Open, Classified ·CareFusion 303, Inc.·Product code FRN·August 15, 2024

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

    FDA Recall
    Open, Classified ·CareFusion 303, Inc.·Product code FRN·August 15, 2024

    Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code FRN·October 2, 2024

    Allegedly counterfeit batteries manufactured by CSB batteries being used with Plum Infusion Systems: Plum 360" Infusion System, Pump List Number 30010; Plum A+ & Plum A+3" Infusion Systems, Pump List Numbers: 11005, 11971, 12391, 12618, 20678, 20679, 20792, 60529, 12348, 1197

    FDA Recall
    Open, Classified ·ICU Medical, Inc.·Product code FRN·October 22, 2024

    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Product Code 35700BAX

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code FRN·November 19, 2024