BEUDAMED
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    CelluTome Epidermal Harvesting System Harvester (5.0 CM) STERILE EO Rx Only Manufactured for: KCI USA, Inc. Part Number CT-H50 or CT-H25 The CelluTome Epidermal Harvesting System is intended to reproducibly cut a thin skin graft for autologous skin grafting.

    FDA Enforcement
    Class II ·Terminated·KCI USA, INC.·January 14, 2015

    BariAir Therapy System The BariAir Therapy System is a risk management treatment system designed for large and / or difficult-to-manage patients. The BariAir Therapy System provides low air-loss pressure management therapy, pulsation, percussion, Turn Assist. flexible patient positioning capabilities and built-in scales for patients weighing 300 Ib* to 850 Ib ([136*-386 kg] including accessories). The BariAir Therapy System is indicated to aid in: " Patients whose body weight and size pose a significant risk or care management issue to the patient or staff during the performance of routine nursing care. " Large patients weighing between 300 Ib* and 850 Ib (136*-386 kg) including accessories. " Large patients who are difficult to turn. " Preventing and treating pressure ulcers. " Large patients requiring percussion therapy.

    FDA Enforcement
    Class II ·Terminated·KCI USA, Inc.·October 3, 2012

    CelluTome Epidermal Harvesting System Harvester (5.0 CM) STERILE EO Rx Only Manufactured for: KCI USA, Inc. Part Number CT-H50 or CT-H25 The CelluTome Epidermal Harvesting System is intended to reproducibly cut a thin skin graft for autologous skin grafting.

    FDA Recall
    Terminated ·KCI USA, INC.·Product code GFD·November 19, 2014

    Bari Maxx II, KCI''s BariMaxx II bariatric bed, P/N 310611, November 2001, KCI The Clinical Advantage, P. O. Box 659508, San Antonio, Texas 78265-9508, Call Toll Free 1-800-531-5346, FAX (210) 308-3998, Http://www.kci1.com

    FDA Recall
    Terminated ·Kinetic Concepts, Inc·Product code FNL·August 16, 2004

    RotoRest Delta Kinetic Therapy System INDICATIONS: Treatment and prevention of pulmonary complications as a result of immobility, Thoracic or lumbar fracture, Cervical traction, Skeletal traction

    FDA Recall
    Terminated ·KCI USA, Inc.·Product code IOQ·June 27, 2012

    CelluTome Epidermal Harvesting System Part number CT-H25 or Part Number CT-H50

    FDA Recall
    Terminated ·KCI USA, Inc.·Product code GFD·May 19, 2014

    1000 ml Canister (with Gel) for InfoV.A.C. and V.A.C.ULTA Therapy Systems (Part Number M8275093/5). The InfoV.A.C. and V.A.C.ULTA Negative Pressure Wound Therapy Systems are integrated wound management systems for use in acute, and extended and care settings. They are intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. Open wound types include chronic, acute, traumatic, subacute, and dehisced wounds, partial thickness burns, ulcers (such as Diabetic, pressure, or venous insufficiency), flaps and grafts. When used on closed surgical incisions they are intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy. All exudates and infectious materials are collected in the canister

    FDA Recall
    Terminated ·KCI USA, INC.·Product code OMP·April 28, 2017

    BariAir Therapy System The BariAir Therapy System is a risk management treatment system designed for large and / or difficult-to-manage patients. The BariAir Therapy System provides low air-loss pressure management therapy, pulsation, percussion, Turn Assist. flexible patient positioning capabilities and built-in scales for patients weighing 300 Ib* to 850 Ib ([136*-386 kg] including accessories). The BariAir Therapy System is indicated to aid in: " Patients whose body weight and size pose a significant risk or care management issue to the patient or staff during the performance of routine nursing care. " Large patients weighing between 300 Ib* and 850 Ib (136*-386 kg) including accessories. " Large patients who are difficult to turn. " Preventing and treating pressure ulcers. " Large patients requiring percussion therapy.

    FDA Recall
    Terminated ·KCI USA, Inc.·Product code FNL·September 17, 2012

    AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. Power Cord #M4268882 used with InfoVAC Model M825999,, InvoVac Canadian Model M8260027, and Vac ATS Model 8259968.

    FDA Recall
    Terminated ·KCI USA, Inc.·Product code OMP·November 4, 2009

    AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. Power Cord M426884 used with VAC ATS Canadian Model M8259994.

    FDA Recall
    Terminated ·KCI USA, Inc.·Product code OMP·November 4, 2009

    AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. Power Cord #340225 used with Activac Model 340000, and ActiVAC (Canadian) Model 340013.

    FDA Recall
    Terminated ·KCI USA, Inc.·Product code OMP·November 4, 2009

    AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. Power Cord #4102204 used with Tricell 60601 Model 212857, First Step Select Model 215200 , and Plexipulse Model 205835.

    FDA Recall
    Terminated ·KCI USA, Inc.·Product code IOQ·November 4, 2009

    Zuma Mobility System Models: Zuma Mobility Assist 412045-01 and Zuma Mobility Trainer 412046-01. Product Usage: Human Non-AC-Powered Patient Lift

    FDA Recall
    Terminated ·KCI USA, Inc.·Product code FSA·April 6, 2012

    AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. Power Cord #4100079 used with Kinair IV Model 22600, Kinair IV 60601 Model 216050, Triadyne Proventa Model 406000, Therapulse ATP/II Models 227800 and 227080.S, Kinair Medsurg Model 201001W, and Kinair Medsurg Pulse Model 40900.

    FDA Recall
    Terminated ·KCI USA, Inc.·Product code IOQ·November 4, 2009

    AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. Power Cord #M4268840 used with First Step All-In-One Canadian French Models 227500-09 and 227500, First Step All-In-One English Model 227500, Therakair Visio Models M8259978 and M6257763 pump only, and Proficare - Canada Model M8259988

    FDA Recall
    Terminated ·KCI USA, Inc.·Product code IKY·November 4, 2009

    RotoRest Delta Kinetic Therapy System INDICATIONS: Treatment and prevention of pulmonary complications as a result of immobility, Thoracic or lumbar fracture, Cervical traction, Skeletal traction

    FDA Enforcement
    Class II ·Terminated·KCI USA, Inc.·November 28, 2012

    KCI RotoProne Critical Care Therapy System buckles for securing patient to the surface during proning therapy, Model 209500. Indicated for treatment and prevention of pulmonary complications.

    FDA Recall
    Terminated ·KCI USA, Inc.·Product code IKZ·February 18, 2011

    KCI Therapulse II Air Suspension Therapy Bed, manufactured by Kinetic Concepts, Inc., San Antonio, TX 78219. Model number 227080

    FDA Recall
    Terminated ·Kinetic Concepts, Inc·Product code INX·March 22, 2004

    KCI BariAir Therapy System; AC-Powered Adjustable Hospital Bed; Bariatric Bed, manufactured by Kinetic Concepts, Inc., San Antonio, Texas

    FDA Recall
    Terminated ·Kinetic Concepts, Inc·Product code FNL·October 21, 1998

    KCI TriaDyne Proventa Critial Care Therapy System, manufactured by Kinetic Concepts, Inc., San Antonio, Texas 78219. Model number 308900

    FDA Recall
    Terminated ·Kinetic Concepts, Inc·Product code IKZ·March 22, 2004