BEUDAMED
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    AMICUS Exchange Kit; Product Usage: This kit is designed for use with the AMICUS separator for the Therapeutic Plasma Exchange (TPE) procedure. Sterilized by irradiation. Sterile fluid path. Non-pyrogenic fluid path.

    FDA Enforcement
    Class II ·Terminated·Fenwal Inc·June 19, 2013

    AMICUS Exchange Kit; Product Usage: This kit is designed for use with the AMICUS separator for the Therapeutic Plasma Exchange (TPE) procedure. Sterilized by irradiation. Sterile fluid path. Non-pyrogenic fluid path.

    FDA Recall
    Terminated ·Fenwal Inc·Product code LKN·May 24, 2013

    Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corp.·November 11, 2015

    GelPOINT Path Transanal Procedural Pack with Epix Electrosurgical L-Hook with Smoke Evacuation, 4x5.5cm and 5mm x 42cm REF TA211 Product Usage: The GelPOINT Path Transanal Access Platform is indicated for multiple instrument or camera access through the anus to perform various diagnostic and/or therapeutic procedures by using additional instruments.

    FDA Enforcement
    Class II ·Terminated·Applied Medical Resources Corp·November 27, 2019

    Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path

    FDA Recall
    Terminated ·Baxter Healthcare Corp.·Product code KDJ·October 6, 2015

    PATH(R) THREAD CUP ADAPTOR, REF 2007-0013, Wright Medical Technology, Inc. Orthopaedic surgical instrument.

    FDA Enforcement
    Class II ·Terminated·Microport Orthopedics INC.·June 11, 2014

    L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path. Sterilized by ethylene oxide.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·October 9, 2019

    GelPOINT Path Transanal Procedural Pack with Epix Electrosurgical L-Hook with Smoke Evacuation, 4x5.5cm and 5mm x 42cm REF TA211 Product Usage: The GelPOINT Path Transanal Access Platform is indicated for multiple instrument or camera access through the anus to perform various diagnostic and/or therapeutic procedures by using additional instruments.

    FDA Recall
    Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code FER·December 12, 2018

    Atrium Express Dry Seal Chest Drain with Sterile Fluid Path Package Model Number: 4050-170N

    FDA Recall
    Terminated ·Atrium Medical Corporation·Product code CAC·November 8, 2006

    PATH(R) THREAD CUP ADAPTOR, REF 2007-0013, Wright Medical Technology, Inc. Orthopaedic surgical instrument.

    FDA Recall
    Terminated ·Microport Orthopedics INC.·Product code LXH·April 30, 2014

    Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are intended for use in the preparation and administration of drug admixtures.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·February 7, 2018

    L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path. Sterilized by ethylene oxide.

    FDA Recall
    Terminated ·Baxter Healthcare Corporation·Product code FKX·October 10, 2018

    Exacta-Mix Calibration Bag, Sterile R, non-pyrogenic fluid path, 250 mL Reorder No. H938 371 3, Manufactured for Baxa Corporation.

    FDA Recall
    Terminated ·Baxa Corporation·Product code KPE·May 26, 2010

    Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are intended for use in the preparation and administration of drug admixtures.

    FDA Recall
    Terminated ·Baxter Healthcare Corporation·Product code KPE·July 27, 2017

    Laparoscope, general; plastic surgery Used for general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments.

    FDA Enforcement
    Class II ·Terminated·Applied Medical Resources Corp·January 16, 2013

    MACROLYTE Premie Dispersive Electrode, REF 440-2400, CONMED CORPORATION. The device is applied to the patient during electrosurgical procedures to provide a path for RF current to leave the patient and return to the generator.

    FDA Enforcement
    Class II ·Terminated·ConMed Corporation·June 11, 2014

    Baxter 2B8011 Empty INTRA VIA Container with PVC Ports, Sterile fluid path, 150 ml, Admixture Products and Accessories. The lntraVia Empty Plastic Container is intended for use in the preparation and administration of drug admixtures.

    FDA Enforcement
    Class I ·Terminated·Baxter Healthcare Corp·November 12, 2014

    Flat Proximal Pressurizer. Bone cement pressurizers are intended to help seal the delivery path between the delivery nozzle and bone in order to pressurize the cement during delivery.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code KIH·January 13, 2012

    ADC Solo & Initia CR 1000, Path Speed CR SP1001, Centricity CR SP1001 and Centricity CR SP 100, image digitizer, components in Agfa''s computed radiography product line.

    FDA Recall
    Terminated ·AGFA Corp.·Product code KPR·November 18, 2005

    Exacta-Mix Valve Set, Six Inlet, Non-Vented, Assembled, Tubing Kit w/Calibration Bag, Sterile R, non-pyrogenic fluid path, 250 mL, Order No. REF 706, Baxa Corporation.

    FDA Recall
    Terminated ·Baxa Corporation·Product code KPE·May 26, 2010