BEUDAMED
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    Cognision, Subject Kit (Clinical Grade), Model 3000- containing Hydro Dot brand Wave Prep cups-electroconductive cream for use with external electrodes. Order No. D5000, Part No. PN-1720 - Product Usage: An electroconductive cream for use with external electrodes to reduce the impedance of the contact between the electrode surface and the skin. The cream is not intended for use with stimulating electrode. The Wave Prep cups are a component in the Subject Kit.

    FDA Recall
    Terminated ·Neuronetrix Solutions, LLC dba Cognision·Product code KOY·November 7, 2019

    Covidien Dover MIDSTREAM KIT CASTILE SOAP Item Code: 2040SA Castile soap towelettes are used to clean the genital area for male and female patients

    FDA Recall
    Terminated ·Covidien LLC·Product code KOY·January 22, 2016

    Wave Prep Tubes (1710-03) and single use cups (17--00-24)

    FDA Recall
    Terminated ·Carroll-Baccari, Inc.·Product code KOY·December 23, 2019

    PediaPrep Tubes (MD0033-T) and Single use cups (MD0033-SUP)

    FDA Recall
    Terminated ·Carroll-Baccari, Inc.·Product code KOY·December 23, 2019

    HydroDot brand: Wave Prep Single use cups, 8.5 gm (0.3 oz) 24/box-Product 1700-24 - Product Usage: An electroconductive cream for use with external electrodes to reduce the impedance of the contact between the electrode surface and the skin. The cream is not intended for use with stimulating electrodes.

    FDA Recall
    Terminated ·Bio-Signal Group Corp.·Product code KOY·October 29, 2019

    Lemon Prep: MD0019T - 4 oz tubes MD0019--SUP - Single Use Cups Skin preparation used to enhance signal quality of patient recording electrodes (i.e. EKG, ECG, etc.)

    FDA Recall
    Terminated ·Carroll-Baccari, Inc.·Product code KOY·September 5, 2019

    Pedia Prep: MD0033T - 4 oz tubes MD0033--SUP - Single Use Cups Skin preparation used to enhance signal quality of patient recording electrodes (i.e. EKG, ECG, etc.)

    FDA Recall
    Terminated ·Carroll-Baccari, Inc.·Product code KOY·September 5, 2019

    Covidien Dover 7 OZ MIDSTREAM W/CAST SOAP Item Code: 24035 Castile soap towelettes are used to clean the genital area for male and female patients

    FDA Recall
    Terminated ·Covidien LLC·Product code KOY·January 22, 2016

    Covidien Dover KIT/STERILE PRESERVE CULT Item Code: 8000SA Castile soap towelettes are used to clean the genital area for male and female patients

    FDA Recall
    Terminated ·Covidien LLC·Product code KOY·January 22, 2016

    MVAP MEDICAL SUPPLIES INC, Mavidon CardioPrep Single, 24 use cups, Re order # MCP-24

    FDA Recall
    Terminated ·Carroll-Baccari, Inc.·Product code KOY·December 23, 2019

    Covidien Dover PREM U/M 14FR SIL FLY Item Code: P4P14SD P400 Castile soap towelettes are used to clean the genital area for male and female patients

    FDA Recall
    Terminated ·Covidien LLC·Product code KOY·January 22, 2016

    Covidien Dover 4.5OZ MIDSTREAM W/CASTILE TOWL Item Code: 24015 Castile soap towelettes are used to clean the genital area for male and female patients

    FDA Recall
    Terminated ·Covidien LLC·Product code KOY·January 22, 2016

    Covidien Dover MIDSTREAM KIT CASTILE SOAP Item Code: 2090SA Castile soap towelettes are used to clean the genital area for male and female patients

    FDA Recall
    Terminated ·Covidien LLC·Product code KOY·January 22, 2016

    Covidien Dover EASY CATCH MIDSTREAM KT W/CAST Item Code: 25015 Castile soap towelettes are used to clean the genital area for male and female patients

    FDA Recall
    Terminated ·Covidien LLC·Product code KOY·January 22, 2016

    Covidien Dover CATCH KIT SOAP Item Code: 5205 Castile soap towelettes are used to clean the genital area for male and female patients

    FDA Recall
    Terminated ·Covidien LLC·Product code KOY·January 22, 2016

    PDI Electrode Prep Pads, Skin Prep B339 are non-sterile alcohol prep pads. They are included in the Spacelabs Healthcare Hook-Up kits. Each kit contains 2-4 pieces of PDI Electrode Prep Pads . Hook-up kits that contain the affected alcohol prep pads are as follows: Aria, Kit Part number 23189-010, Kit, Basic hookup, AA; CardioCall, Kit Part number 23189-020, Kit, Hookup, CardioCall; Aria, Kit Part number 23189-106, Kit, Aria Hookup; Aria, Kit Part number 23189-110, Kit, Aria Hookup; Flashcorder, Kit Part number 23189-111, Kit, Flashcorder Hookup; Aria, Kit Part number 23189-113, Holter Hookup Kit 7 electrode; LifeCard 12, Kit Part number 23189-114, Kit, Hookup, LC12, Multilingual; Aria, Kit Part number 23189-115, Kit, Basic Hookup, AAA; LifeCard, Kit Part number 23189-116, Kit, Holter Hookup, LifeCard; 483, Kit Part number 23189-117, Kit, Holter Hookup 483; Aria, Kit Part number 23189-153, Holter Hookup Kit, 7 electrode; Aria VLC, Kit Part number 23189-207, Kit, Aria Hookup, VLC; EVO, Kit Part number 50-0048, 4 electrode hookup kit without pouch; EVO, Kit Part number 50-0049, 4 electrode hookup kit with pouch; EVO, Kit Part number SK10456, Sample Kit, Disposables. A surgical skin degreaser or an adhesive tape solvent is a device that consists of a liquid such as 1,1,2-trichloro-1,2,2-trifluoroethane; 1,1,1-trichloroethane; and 1,1,1-trichloroethane with mineral spirits intended to be used to dissolve surface skin oil or adhesive tape.

    FDA Recall
    Terminated ·Del Mar Reynolds Medical, Ltd. 1-2 Harforde Ct., Foxholes Business Park Hertford United Kingdom·Product code KOY·October 12, 2011

    HydroDot brand: Wave Prep 4 oz. tubes-Product 1710-03. An electroconductive cream for use with external electrodes - Product Usage: An electroconductive cream for use with external electrodes to reduce the impedance of the contact between the electrode surface and the skin. The cream is not intended for use with stimulating electrodes.

    FDA Recall
    Terminated ·Bio-Signal Group Corp.·Product code KOY·October 29, 2019

    LemonPrep Tubes (MD0019-T) and Single use cups (MD0019-SUP)

    FDA Recall
    Terminated ·Carroll-Baccari, Inc.·Product code KOY·December 23, 2019

    Covidien Dover P400 PREM U/M 16FR SIL COUDE CATH SECURE Item Code: P4P16CSD Castile soap towelettes are used to clean the genital area for male and female patients

    FDA Recall
    Terminated ·Covidien LLC·Product code KOY·January 22, 2016

    Covidien Dover MIDSTREAM KIT RING CASTILE Item Code: 4090SA Castile soap towelettes are used to clean the genital area for male and female patients

    FDA Recall
    Terminated ·Covidien LLC·Product code KOY·January 22, 2016