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    VITROS WorkCentre, Catalog # 6802159, using enGen" Series Automation Systems (Catalog # ENGEN). VITROS WorkCentre is Ortho-Clinical Diagnostics, Inc.''s branded version of Instrument Manager" developed & listed by Data Innovations, Inc. of South Burlington, VT. --- Ortho-Clinical Diagnostics, Rochester, NY.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JQP·March 6, 2006

    Agfa Heartlab Cardiovascular Results Management Product: Versions 2.03 and 2.04. Heartlab, Inc., Westerly, Rhode Island 02891

    FDA Recall
    Terminated ·AGFA Corp.·Product code LLZ·July 27, 2007

    Custom Waste Management Kit, K10-01756/B, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code DQO·September 12, 2008

    Custom Angiographic Kit, K09-MS3084, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. Intended for fluid management convenience.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code OEZ·January 29, 2009

    Acticoat* Moisture Control Dressing, Product Code 20211, Distributed by Smith & Nephew, Inc., Wound Management Division, 11775 Starkey Road, Largo, FL 33773

    FDA Recall
    Terminated ·Smith And Nephew, Inc. Wound Management Division·April 15, 2003

    BacT/VIEW C.30a Software update (P/N 514515-1) diagnostic data management system, bioMerieux, Inc., P. O. Box 15969, Durham, NC 27704-0969 USA

    FDA Recall
    Terminated ·bioMerieux, Inc.·Product code MDB·December 19, 2006

    LifeScan OneTouch Data Management Software Version 1.0, Part Number: 021-722-01(for OneTouch Select and UltraMini (Download) Blood Glucose Meters), LifeScan Inc, Milpitas, CA 95037.

    FDA Recall
    Terminated ·Lifescan Inc·Product code NBW·December 18, 2007

    Custom Cardiac Cath Pack Kit, K09-08945, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. Intended for fluid management convenience when catheterization is required.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code OEZ·January 29, 2009

    Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC71, 2) Model # WC71R (refurbished); used in conjunction with Warming Blankets and Mattresses.

    FDA Recall
    Open, Classified ·Augustine Temperature Management, LLC·Product code DWJ·December 4, 2024

    Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC71, 2) Model # WC71R (refurbished); used in conjunction with Warming Blankets and Mattresses.

    FDA Recall
    Completed ·Augustine Temperature Management, LLC·Product code DWJ·March 14, 2022

    Medrad Avanta Multi-Patient Disposable Hand Controller, Angiographic Injector and Syringe. Catalog number AVA 500 HC, For Use with MEDRAD Avant Fluid Management System, MEDRAD, Inc., Indianola, PA 15051

    FDA Recall
    Terminated ·Medrad Inc·Product code DXT·October 25, 2007

    Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) WC77V; 2) WC77V-DEMO; 3) WC77V-R; used in conjunction with Warming Blankets and Mattresses, veterinary use.

    FDA Recall
    Completed ·Augustine Temperature Management, LLC·Product code DWJ·March 14, 2022

    Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Multiport, Models: 1) Model # WC77, 2) Model # WC77D (Demo), 3) Model # WC77R (Refurbished); used in conjunction with Warming Blankets and Mattresses.

    FDA Recall
    Open, Classified ·Augustine Temperature Management, LLC·Product code DWJ·December 4, 2024

    Jeanes Hospital Custom Cath Procedure Tray, K09T-08945A, Sterile EO, Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan, Utah 84095. Intended for fluid management convenience when catheterization is required.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code OEZ·January 29, 2009

    Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) WC71V; 2) WC71V-DEMO; 3) WC71V-R; used in conjunction with Warming Blankets and Mattresses, veterinary use.

    FDA Recall
    Completed ·Augustine Temperature Management, LLC·Product code DWJ·March 14, 2022

    Jeanes Hospital Custom Cath Procedure Tray, K09T-08945, Sterile EO, Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan, Utah 84095. Intended for fluid management convenience when catheterization is required.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code OEZ·January 29, 2009

    Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC77, 2) Model # WC77D (Demo), 3) Model # WC77R (Refurbished); used in conjunction with Warming Blankets and Mattresses.

    FDA Recall
    Completed ·Augustine Temperature Management, LLC·Product code DWJ·March 14, 2022

    University Health System Custom Cardiac Cath Pack, K09T-02178, Srterile EO, Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan, Utah 84095. Intended for fluid management convenience when catheterization is required.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code OEZ·January 29, 2009

    Laryngoscope Handle, Reusable, Rx, Product Code 4558GSP or 4559LED, Vital Signs Colorado, Inc., 11039 E. Lansing Circle, Englewood, CO 80112. Used for tracheal tube intubations during anesthesia, intensive care, and emergency medical airway management.

    FDA Recall
    Terminated ·Vital Signs Colorado Inc.·Product code CCW·December 20, 2010

    Eon Mini Implantable Pulse Generator (IPG). Advanced Neuromodulation Systems, Inc. Plano, TX. Indicated as an aid in the management of chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain.

    FDA Recall
    Terminated ·Advanced Neuromodulation Systems, Inc·Product code LGW·April 23, 2010