BEUDAMED
    28 results · 77ms · Sources: EU EUDAMED, US FDA

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    BARDEX FOLEY CATHETER

    FDA Adverse Event
    Malfunction ·C.R. BARD, INC-UROLOGICAL DIVISION·Product code KOD·November 4, 1997

    BARD TOUCHLESS MALE CATHETER KIT

    FDA Adverse Event
    Malfunction ·C.R. BARD INC. UROLOGICAL DIVISION·Product code KOD·October 22, 1998

    Bard Foley procedural trays packaged in breather bags. The product is packaged ten units in each shipper box, and are sold sterile for single use. Used to catheterize patients. The finished trays are sold in Tyvek breather bags.

    FDA Enforcement
    Class II ·Terminated·C.R. Bard, Inc., Urological Division·September 19, 2012

    8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated case. The product is sold sterile for single use and is used to provide continuous urinary drainage from the bladder.

    FDA Enforcement
    Class II ·Terminated·C.R. Bard, Inc., Urological Division·October 10, 2012

    Bardex Foley Catheter, 22 Fr 40cc- 20cc Ribbed Balloons, Coleman Model Red Latex, 3 Way Radiopaque, Lubricath Coated, Sterile, Single Use Device, C.R. Bard, Inc., Covington, GA 30014. The catheter is an open whistle tip with two eyes on the same side. It is made of red latex for added catheter stiffness and radiopacity, with a Lubricath hydrophilic coating. This product has 3 lumens; a lumen for drainage, a lumen for inflation of the bladder balloon, and a lumen for inflation of the prostatic balloon.

    FDA Recall
    Terminated ·C.R. Bard, Inc., Urological Division·Product code MJC·August 29, 2002

    Bard UroForce Balloon Dilation Catheter with Glissando Coating * BARD * C.R. Bard, Inc. Covington, Georgia 30014 * 1-800-526-4455 * Sterile/EO

    FDA Recall
    Terminated ·C.R. Bard, Inc., Urological Division·Product code EZN·November 3, 2005

    Bard RespiShield * Closed Suction System with InnoValve * Endotracheal Start Kit * QTY 1 Unit * 14F/4.7mm * Sterile * Rx Only * C.R.Bard, Inc., Covington, GA 30014, 800-526-4455, www. bardmedical.com * Manufactured in Mexico.

    FDA Recall
    Terminated ·C.R. Bard, Inc., Urological Division·Product code BSY·September 28, 2005

    Bard Platinum Class II Flat Wire Stone Basket, Ureteral Stone Dislodger, Rx only, Sterile, C.R.Bard, Inc., Covington, GA 30014

    FDA Recall
    Terminated ·C.R. Bard, Inc., Urological Division·Product code FFL·December 22, 2003

    Bard Dimension Stone Basket, Rx only, Sterile, C.R.Bard, Inc., Covington, GA 30014

    FDA Recall
    Terminated ·C.R. Bard, Inc., Urological Division·Product code FFL·December 22, 2003

    Bard * Davol Reliavac 400 Closed Wound Suction Kit * Sterile/EO * Single use * Medium-Large 3/16'' (15 Fr., 4.7mm) O.D. PVC Drain * 12.5'' (31.7cm) Hole Pattern, X-ray Opaque Stripe Attached Trocar * 400cc Evacuator ** Y-Connecting Tube * * C.R. Bard Inc., Covington, GA 30014. The product contains a 400cc Evacuator, Y-connector with drainage tube and a 3/116 PVC drain with trocar. These components are provided together in a kit but not preassembled.

    FDA Recall
    Terminated ·C.R. Bard, Inc., Urological Division·Product code GBX·August 17, 2005

    Bard StatLock Intravenous (IV) Catheter Stabilization Kit, Catalog number: IVK0124, C.R. Bard, Inc., Covington, GA 30014, USA.

    FDA Recall
    Terminated ·C.R. Bard, Inc., Urological Division·Product code FPA·April 2, 2009

    Bard CritiCore Monitor, Software Version 2.1, Catalog number 000002N, C.R. Bard, Inc., Covington, GA 30014. Intended for multiple uses as it is an electronic battery-operated monitor used in conjunction with a single-use disposable urine collection container and/or a temperature sensing Foley catheter

    FDA Recall
    Terminated ·C.R. Bard, Inc., Urological Division·Product code EXS·November 17, 2010

    8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated case. The product is sold sterile for single use and is used to provide continuous urinary drainage from the bladder.

    FDA Recall
    Terminated ·C.R. Bard, Inc., Urological Division·Product code KOD·September 7, 2012

    Bard Rectal Tubes, 22 French, 20 Long (51 cm), X-Ray Opaque Rubber with Funnel end, Open Tip, One Eye , Non sterile, 12 Each, C.R. Bard, Inc., Covington, GA 30014

    FDA Recall
    Terminated ·C.R. Bard, Inc., Urological Division·Product code KNT·October 28, 2010

    Bard Dispoz-A-Bag, Disposable Urinary Leg Bags, with Flip-Flo Drainage Valve, 19 oz or 32 oz with a Fabric Leg Strap, C.R.Bard, Inc., Covington, GA 30014, Contents Sterile.

    FDA Recall
    Terminated ·C.R. Bard, Inc., Urological Division·Product code FAQ·March 25, 2003

    BardiaComplete Foley Kit, Single use only, Do not resterilize, For urological use only, Reorder: 800518, 18 Fr., Lot 76IN0317, Inflate with 10ml sterile water, Contents: 5cc Silicone Elastomer-Coated Foley Catheter, Waterproof underpad, Synthetic Vinyl Gloves (2), Lubricant, 10cc Syringe (prefilled with sterile water to inflate Foley catheter), Povidone-Iodine swabs (3), CSR Wrap, Plastic Tray. CR.Bard, Inc., Covington,GA 30014, 222.;bardmedical.com.

    FDA Recall
    Terminated ·C.R. Bard, Inc., Urological Division·Product code KOD·February 10, 2004

    Bard Foley procedural trays packaged in breather bags. The product is packaged ten units in each shipper box, and are sold sterile for single use. Used to catheterize patients. The finished trays are sold in Tyvek breather bags.

    FDA Recall
    Terminated ·C.R. Bard, Inc., Urological Division·Product code EZC·June 29, 2012

    BARD FOLEY CATHETER MODEL 18 FR

    FDA Adverse Event
    Malfunction ·BARD UROLOGICAL DIVISION (C.R. BARD INC.)·Product code EYJ·March 7, 1995

    BARD LATEX FREE SILICONE CATH KIT

    FDA Adverse Event
    Malfunction ·BARD UROLOGICAL DIVISION, C.R. BARD, INC.·Product code KOD·July 29, 1997

    BAROL PLATINUM FLAT WIRE STONE BASKET

    FDA Adverse Event
    Injury ·BARD UROLOGICAL DIVISION C.R. BARD, INC.·Product code FFL·September 23, 1997