BEUDAMED
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    Filters FDA Recall × Status: Terminated × Clear all

    Thermoset Room Temperature Closed Loop Injectate Delivery System. 1 unit per Cavity #3 Cavity Deep/20 pieces per case R1-6090

    FDA Recall
    Terminated ·ICU Medical, Inc.·Product code KRB·October 5, 2018

    Pulsiocath PiCCO ProAQT Monitoring Kit, single-use cardiac output (CO) sensor, one unit per plastic sterilizable package. Product Usage: Measures cardiac output by the thermodilution method, measurement of arterial blood pressure, and for cardiac output determination by arterial pulse contour analysis.

    FDA Recall
    Terminated ·Pulsion Medical Inc·Product code KRB·November 4, 2014

    Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #6x12x2.6 Cav/10 pieces per case R1-6090

    FDA Recall
    Terminated ·ICU Medical, Inc.·Product code KRB·October 5, 2018

    Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #2-4"x9" Cav/20 pieces per case R1-15645

    FDA Recall
    Terminated ·ICU Medical, Inc.·Product code KRB·October 5, 2018

    APSOF-7-4-RB, ZIMMON PANCREATIC STENT W/RADIOPAQUE BANDS, Stent Diameter: 7 FR., Length (Between Curl and Flap): 4 CM, For Use With Wilson-Cook Stent Introduction System: 7 FR. Minimum Accessory Channel Size: 2.8 MM., Disposable-Single Use Only, Rx Only, Wilson-Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105

    FDA Recall
    Terminated ·Wilson-Cook Medical Inc·Product code FGE·July 25, 2003

    BD Precision Glide Needle 18G x 1 RB, Catalog 305195 Product Usage: These needles are intended for general purpose fluid injection/aspiration, infusion, venipuncture to obtain blood collection and insulin injection.

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code FMI·May 31, 2017

    VITROS Chemistry Products Mixing Cup Arrays utilized on VITROS 250 & 350 Chemistry Systems Product Usage: Mixing Cup Array is a disposable, intermediate container used in making automatic (auto)-dilutions on the VITROS 250/350 Chemistry Systems. The VITROS 250 Chemistry System is intended for use in the in vitro quantitative, semi quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Microslides. The VITROS 350 Chemistry System is intended for use in the in vitro quantitative, semi quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JRB·October 10, 2013

    Laseredge Knife 1.5mm X 1.7mm TRAPEZOID ANGLED, REF E7599 Product Usage: Available to surgeons for use in ophthalmic surgical procedures.

    FDA Recall
    Terminated ·Bausch & Lomb Inc Irb·Product code HNN·July 11, 2016

    LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.85 (6/BOX), REF/PRODUCT CODE E7528, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.

    FDA Recall
    Terminated ·Bausch & Lomb Inc Irb·Product code HNN·March 3, 2017

    LASEREDGE Knives, 22.5 DEGREE STAB BLADE (6/BOX), REF/PRODUCT CODE E7522, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.

    FDA Recall
    Terminated ·Bausch & Lomb Inc Irb·Product code HNN·March 3, 2017

    LASEREDGE Knives, CRESCENT BLADE ANGLED TIP BEVEL UP (6/BOX), REF/PRODUCT CODE E7510AT, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.

    FDA Recall
    Terminated ·Bausch & Lomb Inc Irb·Product code HNN·March 3, 2017

    LASEREDGE Knives, 30 DEGREE STAB BLADE (6/BOX), REF/PRODUCT CODE E7530, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.

    FDA Recall
    Terminated ·Bausch & Lomb Inc Irb·Product code HNN·March 3, 2017

    LASEREDGE Knives, 15 DEGREE STAB BLADE (6/BOX), REF/PRODUCT CODE E7515, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.

    FDA Recall
    Terminated ·Bausch & Lomb Inc Irb·Product code HNN·March 3, 2017

    PeroxiClear Peroxide Solution, (3oz. and 12 oz., 12 oz. Twin Pack, 2x12 oz. Twin Pack for Target stores, 12 oz. for Walmart Vision Center and 3 oz. Starter Kit US), Manufactured by Bausch + Lomb, Rochester, NY 14609. PeroxiClear 3% Hydrogen Peroxide Cleaning & Disinfecting Solution is indicated for the daily cleaning, removal of protein deposits, disinfection and storage of soft (hydrophilic) contact lenses (including silicone hydrogel) and rigid gas permeable contact lenses.

    FDA Recall
    Terminated ·Bausch & Lomb Inc Irb·Product code LPN·September 19, 2016

    LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.9MM (6/BOX), REF/PRODUCT CODE E7587A, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.

    FDA Recall
    Terminated ·Bausch & Lomb Inc Irb·Product code HNN·March 3, 2017

    LASEREDGE Knives, 3.2MM STRAIGHT SLIT KNIFE (6/BOX), REF/PRODUCT CODE E7557, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.

    FDA Recall
    Terminated ·Bausch & Lomb Inc Irb·Product code HNN·March 3, 2017

    LASEREDGE Knives, 2.5 MM SLIT KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7550A, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.

    FDA Recall
    Terminated ·Bausch & Lomb Inc Irb·Product code HNN·March 3, 2017

    LASEREDGE Knives, 3.0MM SLIT KNIFE ANGLED GUARDED (6/BOX), REF/PRODUCT CODE E7556AG, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.

    FDA Recall
    Terminated ·Bausch & Lomb Inc Irb·Product code HNN·March 3, 2017

    LASEREDGE Knives, 2.0MMX2.2MM TRAPEZOID ANGLED (6/BOX), REF/PRODUCT CODE E7601, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.

    FDA Recall
    Terminated ·Bausch & Lomb Inc Irb·Product code HNN·March 3, 2017

    LASEREDGE Knives, 2.75MM THIN SLIT ANGLED BEVELED UP (6/BOX)(6/BOX), REF/PRODUCT CODE E7759A, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.

    FDA Recall
    Terminated ·Bausch & Lomb Inc Irb·Product code HNN·March 3, 2017