BEUDAMED
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    HALO Ultra Ablation Catheter: Rx only; for use only with the Halo Flex Energy generator and accessories; Manufactured in the USA at BRRX Medical, 540 Oakmead Parkway, Sunnyvale, CA 94085. Product Usage: Indicated for use in the coagulation of bleeding and nod-bleeding sites in the gastrointestinal tract including but not limited to the esophagus.

    FDA Recall
    Terminated ·Barrx Medical, Inc.·Product code GEI·May 25, 2011

    LASSO NAV Duo Loop eco Catheters, Catalog No. D-1354-01, D-1354-02, D-1354-03, D-1354-04, D-1354-05, D-1354-06. LASSO NAV DUO LOOP eco Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The catheter is designed to obtain electrograms in the atrial regions of the heart. LASSO NAV DUO LOOP eco Catheter provides location information when used with compatible CARTO 3 EP Navigation Systems.

    FDA Recall
    Terminated ·Biosense Webster, Inc.·Product code DRF·February 25, 2015

    WRIGHT EVOLVE Proline Head, Size: +2, OD: 22mm, REF 496H222

    FDA Recall
    Terminated ·Wright Medical Technology, Inc.·Product code KWI·December 27, 2019

    WRIGHT EVOLVE Proline Head, Size: +2, OD: 20mm, REF 496H220

    FDA Recall
    Terminated ·Wright Medical Technology, Inc.·Product code KWI·December 27, 2019

    Plicator EPS Plication System Catalog Number: 160-01128R

    FDA Recall
    Terminated ·NDO Surgical, Inc.·Product code KOG·January 26, 2007

    Fungitell STAT- IVD Assay for (1 3)-~-D-Glucan in Serum Ref: FT007

    FDA Recall
    Terminated ·Associates of Cape Cod, Inc.·Product code NQZ·August 17, 2022

    RUSCH, GB: Robinson/Nelaton Catheter, All Purpose PVC 40 Fr. 40 cm, Distributed by Teleflex Medical, Research Triangle Park, NC. Product Usage: Catheter that is inserted through the urethra and used to pass fluids to or from the urinary tract.

    FDA Recall
    Terminated ·Teleflex Medical·Product code KOD·June 30, 2011

    McKESSON Medi-Pak Urethral Catheter Tray with Plastic Catheter Sterile.Single Use.Disposable.Latex-Free 20 Trays Per Case Reorder No. 37-231 Marketed by McKesson Corporation McKesson Medical-Surgical, Richmond, VA 23228 Made in the USA Urethral Catheter Tray with Plastic Catheter

    FDA Recall
    Terminated ·Nurse Assist, Inc·Product code KOD·September 2, 2011

    WELCON TM BRAND REORDER NO. 7305 (STERILE) FOLEY CATHETER TRAY w/o Catheter w/10ml. Prefilled Syringe 20 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com FOLEY CATHETER TRAY w/o Catheter w/10ml. Prefilled Syringe

    FDA Recall
    Terminated ·Nurse Assist, Inc·Product code KOD·September 2, 2011

    REF UT7010 Catheter Insertion Tray 10cc Pre-Filled Syringe with PVP Swabs Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free Manufactured for: Coloplast A/S 3050 Denmark STERILE EO Distributed by: Coloplast Corp. Minneapolis, MN 55411 USA 1-800-328-3863 Distribue par: Coloplast Canada Corporation 3300 Ridgeway Drive Unit 12 Mississauga, Ontario Canada L5L 5Z9 1-905-820-7588 Catheter Insertion Tray 10cc Pre-Filled Syringe with PVP Swabs

    FDA Recall
    Terminated ·Nurse Assist, Inc·Product code KOD·September 2, 2011

    'TORAY' Hydrocoat Foley Catheter 12 x10 4.00 mm Fr x mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed in the wall of the tube. One minor lumen is for inflating the retention balloon (available in 2-Way & 3-Way catheters). The second minor lumen (applicable for 3 Way catheters only) is used for bladder irrigation purposes.

    FDA Recall
    Terminated ·Convatec Inc.·Product code KOD·February 7, 2014

    HydroSil (Intermittent Catheter) Hydrophilic 14 French Male Length REF#63614 Rochester Medical, Distributed by Rochester Medical Ltd 10 Commerce Way, Lancing West Sussex BN158TA, Sterile R, Rochester and HydroSil are registered trademarks of Rochester Medical Corporation. Rochester Medical Corporation, Stewartville, MN 55976. Intended for use for bladder management including urine drainage, collection and measurement.

    FDA Recall
    Terminated ·Rochester Medical Corp·Product code KOD·January 14, 2009

    Magic3 (Intermittent Catheter), Sterile. Uncoated 10 French Pediatric Length REF 52310 Rochester Medical, Rochester Medical Corporation, Stewartville, MN 55976. Intended for use for bladder management including urine drainage, collection and measurement.

    FDA Recall
    Terminated ·Rochester Medical Corp·Product code KOD·January 14, 2009

    Case Label: McKESSON Medi-Pak Urethral Catheter Tray With Plastic Catheter Sterile Single Use Disposable Latex-Free 20 Trays Per Case Reorder No. 37-231 Marketed By McKesson Corporation McKesson Medical-Surgical, Richmond, VA 23228 Made in the U.S.A. Tray Label: McKESSON LATEX FREE Medi-Pak Urethral Catheter Tray With Plastic Catheter Sterile Single Use Disposable Latex-Free Contents: 1-Graduated Tray, 1200 cc, 1-Pair of Vinyl Gloves, 1-Fenestrated Drape, 1-Pack of Three PVP Swabsticks, 1-Specimen Container with Lid and Label, 1-Polylined Drape, 1-Pack of Lubricating Jelly, 1-14 FR Plastic Catheter Reorder No. 37-231 Contents STERILE In unopened, undamaged package. Marketed By McKesson Corporation McKesson Medical-Surgical, Richmond, VA 23228 Intended use: The trays are urological catheter trays.

    FDA Recall
    Terminated ·Nurse Assist, Inc·Product code KOD·January 20, 2011

    Case Label: REORDER NO. 7300 (STERILE) WELCON BRAND URETHRAL CATHETER TRAP w/o Plastic Catheter nurse assist incorporated 20 ea/Box 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com Tray Label: REORDER NO. 7300 STERILE UNLESS OPENED OR DAMAGED nurse assist incorporated A6037, R1 SINGLE USE WELCON BRAND Urethral Catheterization Tray Without Catheter 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com LatexFREE CONTENTS: 1200 mL Graduated Drain Tray Gloves Fenestrated Drape PVP Swabsticks (3) Lube Jelly Specimen Container and Label Waterproof Underpad Intended use: The trays are urological catheter trays.

    FDA Recall
    Terminated ·Nurse Assist, Inc·Product code KOD·January 20, 2011

    Magic3 Intermittent Catheter with Sure Grip Hydrophilic Coated Silicone Coude tip, Product Code 50614. The catheters are packaged in film-to-film pouches and packaged 30 per box. Used as an Intermittent Urinary Catheter

    FDA Recall
    Terminated ·C.R. Bard, Inc.·Product code KOD·August 24, 2015

    Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400mL, Premium, Urine Meter, 16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Adhesive Catheter Securement, Sterile, Product Code P4P16XTSD - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.

    FDA Recall
    Terminated ·Covidien Llc·Product code KOD·April 30, 2020

    400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P16XTSD

    FDA Recall
    Terminated ·COVIDIEN LLC·Product code KOD·July 11, 2018

    Magic3 (Intermittent Catheter), Sterile, Uncoated 6 French Pediatric Length REF # 52306 Rochester Medical, Rochester Medical Corporation, Stewartville, MN 55976. Intended for use for bladder management including urine drainage, collection and measurement.

    FDA Recall
    Terminated ·Rochester Medical Corp·Product code KOD·January 14, 2009

    Magic3 (Intermittent Catheter), Sterile. Hydrophilic 16 French Male Length REF 53616 Rochester Medical, Rochester Medical Corporation, Stewartville, MN 55976. Intended for use for bladder management including urine drainage, collection and measurement.

    FDA Recall
    Terminated ·Rochester Medical Corp·Product code KOD·January 14, 2009