BEUDAMED
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    Pagewriter Touch Cardiograph Software Versions A.01.01 or A.01.02

    FDA Recall
    Terminated ·Philips Medical Systems·Product code DPS·October 13, 2004

    ORA System with VerifEye, Catalog Number 8065998300 For use during intraocular lens surgery

    FDA Recall
    Terminated ·Alcon Research, Ltd.·Product code NCF·June 30, 2017

    Spline Twist Implant, HA 3.25mmD X 15mmL; Part No. 2135. Zimmer Dental Spline implant systems are designed for use in edentulous mandibles or maxillae for attachment of complete denture prostheses for immediate or conventional loading, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a free standing single tooth replacement.

    FDA Recall
    Terminated ·Zimmer Dental Inc·Product code DZE·October 1, 2014

    ORA System with VerifEye, Catalog Number 8065998300 For use during intraocular lens surgery

    FDA Enforcement
    Class II ·Terminated·Alcon Research, Ltd.·August 30, 2017

    ORA System with VerifEye+ Cart, Catalog Number 8065998307 For use during intraocular lens surgery

    FDA Recall
    Terminated ·Alcon Research, Ltd.·Product code NCF·June 30, 2017

    Spline Twist Implant, HA 3.25mmD X 15mmL; Part No. 2135. Zimmer Dental Spline implant systems are designed for use in edentulous mandibles or maxillae for attachment of complete denture prostheses for immediate or conventional loading, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a free standing single tooth replacement.

    FDA Enforcement
    Class II ·Terminated·Zimmer Dental Inc·November 5, 2014

    ORA System with VerifEye+ Cart, Catalog Number 8065998307 For use during intraocular lens surgery

    FDA Enforcement
    Class II ·Terminated·Alcon Research, Ltd.·August 30, 2017

    LifeCare 5000 Pump (Plum 1.6) infusion pump, indicated for volumetric infusion of critical drugs and fluids by intravenous (I.V.) administration.

    FDA Enforcement
    Class II ·Terminated·Hospira Inc.·June 11, 2014

    Plum XL3 Multi line Infusion System, Micro Macro Plum XL3 Multi line Infusion System, and Micro Macro Plum XL Infusion System. Infusion pumps for intravenous. arterial, short-term epidural, and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products to patients in hospital and home care environments.

    FDA Enforcement
    Class II ·Terminated·Hospira Inc.·June 11, 2014

    Plum XL, Micro Macro Plum XL3 with data port, and Micro Macro Plum XL with data port infusion pumps, indicated for intravenous, arterial, short-term epidural, and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products to patients in hospital and home care environments.

    FDA Enforcement
    Class II ·Terminated·Hospira Inc.·June 11, 2014

    Nimbus Administration Set, REF HS-004, UDI # 00817170020031 Product Usage: Administer fluids/medication from a container to a patient through a needle or a catheter.

    FDA Recall
    Terminated ·InfuTronix LLC·Product code FRN·May 28, 2019

    Nimbus Administration Set, REF HS-004, UDI # 00817170020031 Product Usage: Administer fluids/medication from a container to a patient through a needle or a catheter.

    FDA Enforcement
    Class II ·Terminated·InfuTronix LLC·July 31, 2019

    SIEMENS Luminos Agile Max; a universal imaging system for radiographic and fluoroscopic studies. Using either film cassettes or a digital mobile flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. Luminos Agile is applicable to emergency treatment on an outpatient basis, as well as for bedside examinations.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·June 3, 2015

    Philips M3015A Microstream CO2 Extension Model No. 862393 -used with an lntelliVue X3 Patient Monitor (Model No. 867030) or a lntelliVue MMX Multi-Measurement Module (Model No. 867036)

    FDA Recall
    Terminated ·Philips North America, LLC·Product code DSI·June 8, 2020

    Philips M3015A Microstream CO2 Extension Model No. 862393 -used with an lntelliVue X3 Patient Monitor (Model No. 867030) or a lntelliVue MMX Multi-Measurement Module (Model No. 867036)

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·July 15, 2020

    Cardinal Health, Craig Calibrated Cannula, overall length 5-3/8" (13.7 cm), catalog #OS5000-005, sold separately, or as a component of the Craig Vertebral Biopsy Set, catalog #OS5000

    FDA Recall
    Terminated ·Cardinal Health·Product code FCG·August 28, 2009

    ProTrack Microcatheter; Product Usage: The ProTrack Microcatheter is a sterile, single use device intended to be used as a standard infusion wire or as an exchange guide for exchanging guidewires.

    FDA Recall
    Terminated ·Baylis Medical Corp 5959 TransCanada Highway Montreal Canada·Product code DQX·March 30, 2015

    ProTrack Microcatheter; Product Usage: The ProTrack Microcatheter is a sterile, single use device intended to be used as a standard infusion wire or as an exchange guide for exchanging guidewires.

    FDA Enforcement
    Class II ·Terminated·Baylis Medical Corp *·April 22, 2015

    PowerPICC Provena Catheters, as 3 Fr. Single lumen and 4 Fr. Dual Lumen. Packaged in a poly tray with Tyvek lid within a header bag configuration or a breather bag configuration.

    FDA Recall
    Terminated ·Bard Access Systems Inc.·Product code LJS·December 28, 2017

    PowerPICC Provena Catheters, as 3 Fr. Single lumen and 4 Fr. Dual Lumen. Packaged in a poly tray with Tyvek lid within a header bag configuration or a breather bag configuration.

    FDA Enforcement
    Class II ·Terminated·Bard Access Systems Inc.·February 14, 2018