BEUDAMED
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    U19 Socketed Integrated Circuit ("U19 IC") on the logic board of Alaris Pump modules (aka. Medley Pump modules), Model 8100 built on or before September 8, 2005. CardinalHealth, San Diego, CA 92130

    FDA Recall
    Terminated ·Cardinal Health 303 Inc DBA Alaris Products·Product code FRN·March 5, 2008

    U9 Socket Integrated Circuit ("U9 IC") on the display board of the following Alaris System modules built on or before October 4, 2005: (1) Alaris Syringe module (Model 8110) (a.k.a. Medley Syringe module) (2) Alaris PCA module (Model 8120) (a.k.a. Medley PCA module), CardinalHealth, San Diego, CA 92130

    FDA Recall
    Terminated ·Cardinal Health 303 Inc DBA Alaris Products·Product code FRN·March 5, 2008

    Grey Inter-Unit Interface Connectors ("IUI") on the following Alaris System modules built on or before March 26, 2004: (1) Alaris PC point-of-care unit ("PC Unit") (Model 8000)* (a.k.a. Medley PC Unit), (2) Alaris Pump Module (Model 8100) (a.k.a. Medley Pump Module), (3) Alaris Syringe Module (Model 8110) (a.k.a. Medley Syringe Module), (4) Alaris PCA Module (Model 8120) (a.k.a. Medley PCA Module), (5) Alaris SpO2 Module (Models 8210) (a.k.a. Medley SpO2 Module) with Nellcor technology, and (6) Alaris SpO2 Module (Models 8220) (a.k.a. Medley SpO2 Module) with Masimo technology, CardinalHealth, San Diego, CA 92130

    FDA Recall
    Terminated ·Cardinal Health 303 Inc DBA Alaris Products·Product code FRN·March 5, 2008

    ClariVein IC infusion catheter, Model Number: 65-018-E4S Product Usage: The ClariVein IC infusion catheter is indicated for infusion of physician-specified agents into the peripheral vasculature.

    FDA Recall
    Terminated ·Vascular Insights, LLC·Product code KRA·November 9, 2017

    MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays. Product Number: 8888222316.

    FDA Recall
    Terminated ·Medtronic Minimally Invasive Therapies Group·Product code MPB·October 14, 2017

    Image Consultant (IC) Software

    FDA Recall
    Terminated ·R.O. Gulden & Co., Inc.·Product code NFF·February 5, 2010

    The Arrow Edge Hemodialysis Catheterization Set Long-Term Access and NextStep Antegrade Hemodialysis Catheterization Set, Long-Term Access, part numbers: AC-15192-SFX, AC-15232-SFX, AC-15272-SFX, AC-15312-SFX, AC-15422-SFX, CS-15192-SFX, CS-15192-SFXM, CS-15232-SFX, CS-15242-I, CS-15272-SFX, CS-15282-I, CS-15312-SFX, CS-15322-I, CS-15362-I, CS-15422-SFX, CS-15502-SFX, CS-15552-I, CSD-15242-I, CSD-15282-I, and CSD-15322-I. The Arrow Edge Hemodialysis Catheterization Set and NextStep Antegrade Hemodialysis Catheterization Set is indicated for use in attaining long- term vascular access for hemodialysis and apheresis.

    FDA Recall
    Terminated ·Arrow International Inc·Product code MSD·February 4, 2013

    The ICS CHARTR EP 200

    FDA Recall
    Terminated ·GN Otometrics Horskatten 9 Taastrup Denmark·Product code GWJ·May 28, 2019

    Draeger Globe Trotter IC, Catalog Number: MU20509, Draeger Medical, Inc., Telford, PA 18969

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code FMZ·January 31, 2008

    Intesys Clinical Suite (ICS) G2 92810 Smart Disclosure. The Smart Disclosure product collects patient waveforms, alarms, vital signs and 12-lead reports. A 24-hour waveform acquisition is standard, with an upgrade option to 72 hours. The product provides basic trends in both tabular and graphical format, along with a retrospective ECG analysis. The analysis may be defined by patient, and the data may be presented in multiple formats, including a rhythm, a histogram, and a summary view. Standard reports are available from Smart Disclosure, including saved events, disclosure, trends histogram and summary.

    FDA Recall
    Terminated ·Spacelabs Healthcare, Incorporated·Product code DQK·October 17, 2008

    Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2.

    FDA Recall
    Terminated ·Spacelabs Healthcare, Inc.·Product code DQK·January 28, 2019

    NucliSENS Lysis Buffer Extended lot for RES 76675

    FDA Recall
    Terminated ·BioMerieux SA Chemin De L'Orme Marcy L'Etoile France·Product code PPM·October 18, 2017

    Amplicor [3] AV-HRP, Avidin-HRP (Horseradish Peroxidase) BGG Conjugate. Kit: AMPLICOR IC Detection Kit, Export, IVD/CE.

    FDA Recall
    Terminated ·Roche Molecular Systems Inc·July 7, 2004

    Amplicor [3] AV-HRP. (Avidin-HRP (Horseradish Peroxidase) BGG Conjugate.) Kit: Amplicor IC Detection Kit, 96 test [General Purpose]

    FDA Recall
    Terminated ·Roche Molecular Systems Inc·July 7, 2004

    RTI Biologics BioSet IC RT Paste 2 cc Filler, bone void, calcium compound. Use in dental, spine and orthopedic applications

    FDA Recall
    Terminated ·RTI Surgical, Inc.·Product code MQV·January 23, 2017

    Product is Regenafil IC. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.

    FDA Recall
    Terminated ·Regeneration Technologies, Inc.·Product code MQV·October 14, 2005

    Osteofil IC Syringeable of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.

    FDA Recall
    Terminated ·Regeneration Technologies, Inc.·Product code MQV·October 14, 2005

    Osteofil IC Syringeable of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.

    FDA Recall
    Terminated ·Regeneration Technologies, Inc.·Product code MQV·October 14, 2005

    Spacelabs Smart Disclosure System, Model 92810, is an integrated component of the Intesys Clinical Suite (ICS) G2, Version 4.03. The Smart Disclosure product collects patient waveforms, alarms, vital signs, and 12-lead reports. A 24-hour waveform acquisition is standard, with an upgrade option to 72 hours. The product provides basic trends in both tabular and graphical format, along with a retrospective ECG analysis. The analysis may be defined by patient, and the data may be presented in multiple formats, including a rhythm, a histogram, and a summary view. Standard reports are available from Smart Disclosure, including saved events, disclosure, trends, histogram, and summary. The Spacelabs Smart Disclosure System, Model 92810 is indicated for use in clinical situations where there is a need for review of physiological waveform information and alarm events up to 72 hours after the fact. Smart Disclosure is also indicated in those situations where a retrospective analysis of monitoring patients' ECG waveform data, that can be annotated and edited, is desired. The intended use of the Spacelabs Smart Disclosure is to interface with the Spacelabs monitoring network, providing the user with a means of recalling waveform information and performing retrospective analysis. The most recent 72 hours of monitored patient ECG waveform data can be analyzed, with each analysis limited to 24 hours or less.

    FDA Recall
    Terminated ·Spacelabs Healthcare, Llc·Product code DQK·December 5, 2012

    RUSCH, Pocket PAC IC Intermittent Cath Kit, 8 FR, 12 FR, 14 FR, 10 FR and 16 FR, Rx Only, Sterile, Intermittent self-catheterization

    FDA Recall
    Terminated ·Teleflex Medical·Product code KOD·November 22, 2016