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    IMx Tacrolimus II Calibrators, list 3C10-10; the pack contains six 4.5-mL bottles, with Calibrator A having 0 ng/mL, Calibrator B having 3 ng/mL, Calibrator C having 6 ng/mL, Calibrator D having 12 ng/mL, Calibrator E having 20 ng/mL and Calibrator F having 30 U/mL; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories HPD/ADD/GPRD·Product code MLM--·September 19, 2003

    ARCHITECT STAT Myoglobin Calibrators; list 02K43-01; each kit contains 6 bottles of calibrators ranging from 0 ng/mL to 1200 ng/mL; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories MPG·Product code DDR·October 17, 2005

    Abbott AxSYM Cancer Assay Disk Version 5.0, for in vitro diagnostic use with the AxSYM System; Abbott Laboratories, Abbott Park, IL 60064; List Number 3D50-05. AxSYM AFP is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of alpha-fetoprotein (AFP).

    FDA Recall
    Terminated ·Abbott Laboratories·Product code LOJ·February 20, 2009

    IMMULITE 1000 Progesterone, Model LKPW1, SMN Number 10381128

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JLS·July 10, 2019

    IMMULITE 2000 Progesterone; Models US: L2KPW2, L2KPW6 and OUS: L2KPW2(D), L2KPW6(D); SMN Numbers US: 10901873, 10901874 and OUS 10381181, 10381170

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JLS·July 10, 2019

    DeVilbiss Model DV5x Series CPAP with Heated Humidifier Device is intended to treat Obstructive Sleep Apnea (OSA) in patients weighing 30 Kg and above. The device creates a positive pressure in the patient's airway to prevent collapse of the airway while the patient is sleeping. The heated humidifier provides additional humidity to the air supplied to the patient. The heated humidifier has a removable water chamber for filling with water and ease of cleaning.

    FDA Recall
    Terminated ·Sunrise Medical HHG Inc. dba DeVilbiss Healthcare·Product code BZD·March 11, 2011

    GDC-10 360 10mm x 30cm SR ; GDC 360 Detachable Coils are intended for embolization of those intracranial aneurysms that- because of their morphology, their location, or the patient 's general medical condition - are considered by the treating neurosurgical team to be a) very high risk for management by traditional operative techniques, or b) inoperable

    FDA Recall
    Terminated ·Stryker Neurovascular·Product code HCG·October 22, 2014

    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

    GDC-18 360 11MM X 30CM Detachable Coil Sterile; Model number: M0033471020SR0 Neurology: GDC 360 degree Detachable Coils are intended for embolization of those intracranial aneurysms thata because of their morphology, their location, or the patients general medical condition are considered by the treating neurosurgical team to be a) very high risk for management by traditional operative techniques, or b) inoperable.

    FDA Recall
    Terminated ·Stryker Neurovascular·Product code HCG·March 21, 2016

    Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 1 CM MODEL Number:M0035431510 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.

    FDA Recall
    Terminated ·Stryker Neurovascular·Product code HCG·June 6, 2016

    MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization Coil, HydroSoft 3D, Sterile, Rx, REF numbers 100102HFRM-V, 100152HFRM-V, 100153HFRM-V, 100154HFRM-V, 100202HFRM-V, 100206HFRM-V, 100208HFRM-V, 100254HFRM-V, 100256HFRM-V, 100308HFRM-V, MV-00202HHTA, MV-00203HHTA, MV-00204HHTA, MV-00206HHTA, MV-00208HHTA, MV-00304HHTA, MV-00306HHTA, MV-00308HHTA, MV-00310HHTA, MV-00408HHTA, MV-00412HHTA, MV-00510HHTA, MV-00515HHTA, MV-00612HHTA, MV-00619HHTA, MV-00715HHTA, MV-00728HHTA, MV-00817HHTA, MV-00833HHTA, MV-01502HHTA, MV-01503HHTA, MV-01504HHTA, MV-02504HHTA, MV-02506HHTA, and MV-02508HHTA. Product Usage: The HES is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature. The firm name on the label is MicroVention, Inc., Tustin, CA.

    FDA Recall
    Terminated ·Microvention, Inc.·Product code HCG·November 22, 2019

    MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, HyperSoft 3D, Sterile, Rx, REF numbers 100102HS3D-V, 100103HS3D-V, 100152HS3D-V, 100153HS3D-V, 100154HS3D-V, 100202HS3D-V, 100203HS3D-V, 100204HS3D-V, 100206HS3D-V, 100208HS3D-V, 100254HS3D-V, 100256HS3D-V, 100304HS3D-V, 100306HS3D-V, 100310HS3D-V, 100355HS3D-V, 100358HS3D-V, 100406HS3D-V, 100408HS3D-V, 100412HS3D-V, 100415HS3D-V, 100510HS3D-V, 100515HS3D-V; MV-00102HTDA, MV-00103HTDA, MV-00204HTDA,MV-00304HTDA, MV-00306HTDA, MV-00406HTDA, MV-00408HTDA, MV-00510HTDA, MV-01502HTDA, MV-01503HTDA, MV-01504HTDA; MV-02504HTDA, MV-02506HTDA, MV-03505HTDA, and MV-03508HTDA. Product Usage: The MCS is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature. The firm name on the label is MicroVention, Inc., Tustin, CA.

    FDA Recall
    Terminated ·Microvention, Inc.·Product code HCG·November 22, 2019

    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

    UNO 100 EM/EE Patient Lift

    FDA Recall
    Terminated ·Liko, Inc.·Product code FNG·September 24, 2004

    Penner Manufacturing Patient Transfer/Lift System, Cascade Transfer, Models 380000-1 (white) and 380000-2 (gray). The firm name on the label is Penner Manufacturing Inc., Aurora, NE. For use with bathing systems in nursing homes, hospitals, and assisted living facilities to transfer or lift patients under the direct supervision of trained staff.

    FDA Recall
    Terminated ·Penner Mfg Inc·Product code FNG·January 19, 2009

    Penner Manufacturing Transfer Electric Pacific Chair with scale, Patient Transfer/Lift System, Models 394000-1. The firm name on the label is Penner Manufacturing Inc., Aurora, NE. For use with bathing systems in nursing homes, hospitals, and assisted living facilities to transfer or lift patients under the direct supervision of trained staff.

    FDA Recall
    Terminated ·Penner Mfg Inc·Product code FNG·January 19, 2009

    GDC-18 360 20mm x 33cm ; GDC 360 Detachable Coils are intended for embolization of those intracranial aneurysms that- because of their morphology, their location, or the patient 's general medical condition - are considered by the treating neurosurgical team to be a) very high risk for management by traditional operative techniques, or b) inoperable

    FDA Recall
    Terminated ·Stryker Neurovascular·Product code HCG·October 22, 2014

    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