BEUDAMED
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    MicroCool Breathable Impervious Gown with Secure Fit Surgical, (Large and X-Large), Made in Honduras. The Kimberly Clark Micro COOL Surgical Gowns are sterile single use surgical apparel intended to be worn by heathcare professionals to help protect the patient and the healthcare worker from the transfer of microorganisms, body fluids and particulate matter.

    FDA Enforcement
    Class II ·Terminated·Kimberly-Clark Corporation·July 25, 2012

    MicroCool Breathable Impervious Surgical Gown, (Large and X-Large), Sterile, Made in Honduras. The Kimberly Clark Micro COOL Surgical Gowns are sterile single use surgical apparel intended to be worn by heathcare professionals to help protect the patient and the healthcare worker from the transfer of microorganisms, body fluids and particulate matter.

    FDA Enforcement
    Class II ·Terminated·Kimberly-Clark Corporation·July 25, 2012

    MicroCool Breathable Impervious Gown with Secure Fit Surgical, (Large and X-Large), Made in Honduras. The Kimberly Clark Micro COOL Surgical Gowns are sterile single use surgical apparel intended to be worn by heathcare professionals to help protect the patient and the healthcare worker from the transfer of microorganisms, body fluids and particulate matter.

    FDA Recall
    Terminated ·Kimberly-Clark Corporation·Product code FYA·September 17, 2009

    MicroCool Breathable Impervious Surgical Gown, (Large and X-Large), Sterile, Made in Honduras. The Kimberly Clark Micro COOL Surgical Gowns are sterile single use surgical apparel intended to be worn by heathcare professionals to help protect the patient and the healthcare worker from the transfer of microorganisms, body fluids and particulate matter.

    FDA Recall
    Terminated ·Kimberly-Clark Corporation·Product code FYA·September 17, 2009

    Applied Medicals Epix¿ and Direct Drive Laparoscopic Graspers, Model Numbers C4130 and C4140. Used for grasping and manipulating tissue during general or laparoscopic surgery.

    FDA Enforcement
    Class II ·Terminated·Applied Medical Resources Corp·June 19, 2013

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, Models N118 and N119. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 66112-5798, USA. The product is indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support. COGNIS devices also provide bi-ventricular pacing.

    FDA Recall
    Terminated ·Boston Scientific CRM Corp·Product code LWP·July 20, 2009

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator, Models E102 and E110. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 66112-5798, USA. The product is indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support. COGNIS devices also provide bi-ventricular pacing.

    FDA Recall
    Terminated ·Boston Scientific CRM Corp·Product code LWP·July 20, 2009

    Spectranetics SLS II Laser Sheath Kit, 14F, REF 500-012, Individually packaged catheter introducer.

    FDA Recall
    Terminated ·Spectranetics Corporation·Product code OEX·March 16, 2009

    Exacta Mix TPN (total parenteral nutrition) Bag, Model 740, 2000mL, Baxa Corporation

    FDA Recall
    Terminated ·Baxa Corporation·Product code KPE·November 12, 2009

    POWERSAIL Coronary Dilatation Catheter: 3.25x18mm (US) Part #1005524-18

    FDA Recall
    Terminated ·Abbott Vascular-Cardiac Therapies dba Guidant Corporation·Product code MAF·June 17, 2009

    POWERSAIL Coronary Dilatation Catheter: 4.0x8mm (CE) Part #1005726-08

    FDA Recall
    Terminated ·Abbott Vascular-Cardiac Therapies dba Guidant Corporation·Product code MAF·June 17, 2009

    Exacta Mix TPN (total parenteral nutrition) Bag, Model 738, 500mL, Baxa Corporation.

    FDA Recall
    Terminated ·Baxa Corporation·Product code KPE·November 12, 2009

    POWERSAIL Coronary Dilatation Catheter: 2.75x18mm (US) Part #1005522-18

    FDA Recall
    Terminated ·Abbott Vascular-Cardiac Therapies dba Guidant Corporation·Product code MAF·June 17, 2009

    Exacta Mix TPN (total parenteral nutrition) Bag, Model 739, 1000mL, Baxa Corporation

    FDA Recall
    Terminated ·Baxa Corporation·Product code KPE·November 12, 2009

    POWERSAIL Coronary Dilatation Catheter: 3.25x8mm (US) Part #1005524-08

    FDA Recall
    Terminated ·Abbott Vascular-Cardiac Therapies dba Guidant Corporation·Product code MAF·June 17, 2009

    Varian Medical Systems, Eclipse Proton Convolution Superposition DCF, version 8.6.15, Model H48, radiation therapy treatment planning system.

    FDA Recall
    Terminated ·Varian Medical Systems Oncology Systems·Product code MUJ·July 17, 2009

    Stryker Medical transport stretcher, Stryker Medical, Portage, MI; Model 736. Wheeled hospital stretcher.

    FDA Recall
    Terminated ·Stryker Medical Div. of Stryker Corporation·Product code FPO·August 10, 2009

    Stryker Medical trauma stretcher, Stryker Medical, Portage, MI; Model 1027. Wheeled hospital stretcher.

    FDA Recall
    Terminated ·Stryker Medical Div. of Stryker Corporation·Product code FPO·August 10, 2009

    Stryker Medical transport stretcher, Stryker Medical, Portage, MI; Model 734. Wheeled hospital stretcher.

    FDA Recall
    Terminated ·Stryker Medical Div. of Stryker Corporation·Product code FPO·August 10, 2009

    Stryker Medical eye surgery stretcher, Stryker Medical, Portage, MI; Model 1079. Wheeled hospital stretcher.

    FDA Recall
    Terminated ·Stryker Medical Div. of Stryker Corporation·Product code FPO·August 10, 2009