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    BD FlowSmart Set MiniMed Pro-set Rx Only Distributed by Medtronic MiniMed Inc. 8006464633 8185765555 Legal Manufacturer Becton, Dickinson and Company USA BD Medical-Diabetes Care Becton Dickinson France SAS

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code FPA·December 23, 2016

    Cloward Spanner gauges are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion and Boss Instruments brand names.

    FDA Recall
    Terminated ·Instrumed International, Inc.·Product code HBG·September 8, 2014

    Ref No: HITHSP04 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.

    FDA Recall
    Open, Classified ·Integra LifeSciences Corp.·Product code HBG·January 19, 2024

    Ref No: HITHSP06 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.

    FDA Recall
    Open, Classified ·Integra LifeSciences Corp.·Product code HBG·January 19, 2024

    Hand Drill - Sterile, Disposable, Convenience Kit, Reorder Number INS030, Integra LifeSciences Corporation, Salt Lake City, Utah 84104. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures.

    FDA Recall
    Terminated ·Integra Life Sciences Corporation·Product code HBG·July 13, 2009

    McKenzie Perforator Drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Phoenix Instruments, Stealth Surgical, CareFusion, and Boss Instruments brand names.

    FDA Recall
    Terminated ·Instrumed International, Inc.·Product code HBG·September 8, 2014

    McKenzie enlarging burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion and Boss Instruments brand names.

    FDA Recall
    Terminated ·Instrumed International, Inc.·Product code HBG·September 8, 2014

    CVB distraction screws are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Millennium Surgical, Medfix International, CareFusion, Boss Instruments, Medline Industries, Surgical Direct, and Teleflex Medical brand names.

    FDA Recall
    Terminated ·Instrumed International, Inc.·Product code HBG·September 8, 2014

    Integra Cranial Access Kit -For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7270

    FDA Recall
    Open, Classified ·Integra LifeSciences Corp.·Product code HBG·October 19, 2023

    Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND

    FDA Recall
    Terminated ·Integra LifeSciences Corp. d.b.a. Integra Pain Management·Product code HBG·August 24, 2016

    Ref No: INSHITHRZN / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.

    FDA Recall
    Open, Classified ·Integra LifeSciences Corp.·Product code HBG·January 19, 2024

    Ventricular Bolt Monitoring Kit W/Cranial Access, Drain, 1104HMC, Integra LifeSciences, 3498 West 2400 South, West Valley City, Utah 84119. Kit contains components which are used to monitor Intra Cranial Pressure and provide access to the cerebral ventricles for Cerebro-spinal fluid sampling, drainage and fluid injection.

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code HBG·February 22, 2011

    1104BC Combo Kit including 1 Cranial Kit w/Cam Chuck, 1 OLM Intracranial Pressure Monitoring Kit, contains sterile and non-sterile product. Integra NeuroSciences, Integra LifeSciences 3498 West 2400 South, West Valley City, Utah 84119. Product Usage: The Xylocaine component of the kit is used as an injectable local anesthetic during cranial access operations.

    FDA Recall
    Terminated ·Integra LifeSciences Corp. d.b.a. Integra Pain Management·Product code HBG·December 21, 2011

    Cranial Access Kit Ref HITHSP06 Integra NeuroSciences Plainsboro, NJ 08536 Sterile and non-sterile contents, Single use device, Do not resterilize, Prep and Closure Kit Contents Sterile & Non-Sterile, (1) Lidocaine 1.5% w/ Epinephrine (30 ml VIAL). Sterile EO, Contents 5 units. Product Usage: The Xylocaine component of the kit is used as an injectable local anesthetic during cranial access operations.

    FDA Recall
    Terminated ·Integra LifeSciences Corp. d.b.a. Integra Pain Management·Product code HBG·December 21, 2011

    Ref No: INSHITH / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.

    FDA Recall
    Open, Classified ·Integra LifeSciences Corp.·Product code HBG·January 19, 2024

    Combo Kit Consists OF 10-110/INS-4500/INS-7040- For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: 31004

    FDA Recall
    Open, Classified ·Integra LifeSciences Corp.·Product code HBG·October 19, 2023

    Ref No: 31156 / COMBO KIT CONTAINS INS-8301, INS-4500,INS-HITH. For access to the subarachnoid space or the lateral ventricles of the brain.

    FDA Recall
    Open, Classified ·Integra LifeSciences Corp.·Product code HBG·January 19, 2024

    Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: HITHSP04

    FDA Recall
    Open, Classified ·Integra LifeSciences Corp.·Product code HBG·October 19, 2023

    Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7280

    FDA Recall
    Open, Classified ·Integra LifeSciences Corp.·Product code HBG·October 19, 2023

    Integra Cranial Access Kit - For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7040

    FDA Recall
    Open, Classified ·Integra LifeSciences Corp.·Product code HBG·October 19, 2023