BEUDAMED
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    TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION TheraSphere¿ is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable HCC who can have placement of appropriately positioned hepatic arterial catheters.

    FDA Enforcement
    Class II ·Terminated·Biocompatibles U.K., Ltd.·October 19, 2016

    TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION TheraSphere is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable HCC who can have placement of appropriately positioned hepatic arterial catheters.

    FDA Recall
    Terminated ·Biocompatibles U.K., Ltd. Bortoli House Weydon Lane; Old Farnham Lane Farnham United Kingdom·Product code NAW·September 21, 2015

    AngioDynamics Angiographic catheter --- Soft-Vu (JB-1) Non-braided. --- Size: 5F; Length: 100cm; designed to accept guidewire: .035 in. --- Catalog No. [REF]: 10734201. Packaged in boxes of 5 catheters each, with manufacturer listed as AngioDynamics, Inc., Queensbury, NY USA. Intended use: angiographic diagnosis.

    FDA Recall
    Terminated ·Angiodynamics Worldwide Headquarters·Product code DQO·June 15, 2012

    AngioDynamics Angiographic catheter --- Soft-Vu (JB-1) Non-braided. --- Size: 5F; Length: 100cm; designed to accept guidewire: .035 in. --- Catalog No. [REF]: 10734201. Packaged in boxes of 5 catheters each, with manufacturer listed as AngioDynamics, Inc., Queensbury, NY USA. Intended use: angiographic diagnosis.

    FDA Enforcement
    Class II ·Terminated·Angiodynamics Worldwide Headquarters·August 15, 2012

    Boston Scientific, IMAGER II Urology Torque Catheter, Sterilized with ethylene oxide gas. Made in Ireland, Manufactured for Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537. The following products being recalled: Imager" II Catheters C1 5fr 65cm M0064003001 M0064003000 400-300 Imager" II Catheters C2 5fr 65cm M0064003011 M0064003010 Catalog # 400-301 Imager" II Catheters Straight 5fr 65cm M0064003021 M0064003020 Catalog #400-302 Imager" II Catheters Bern 5fr 65cm M0064003031 M0064003030 Catalog #400-303 Imager" II Catheters JB1 5fr 65cm M0064003041 M0064003040 Catalog #400-304 Imager" II Catheters Straight 5fr 100cm M0064004021 M0064004020 Catalog #400-402 Imager" II Catheters Bern 5fr 100cm M0064004031 M0064004030 Catalog #400-403 Imager" II Catheters JB1 5fr 100cm M0064004041 M0064004040 Catalog #400-404 Imager" II Catheters Bern 5fr 40cm M0064005031 M0064005030 Catalog #400-503 The Imager II Urology Torque Catheter is indicated for use in facilitating access to the urinary tract, either through a retrograde or antegrade route, and may be used in conjunction with a guidewire or for the infusion of radiopaque contrast material. The Imager II Urology Torque Catheter is also indicated for the infusion of gels, such as BackStop", intended for use in the urinary tract.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code KOD·March 15, 2012

    KTV0006-002, AOS Tongue And Soft Tissue Kit: AOS Tngue And Soft Tissue Inplant Tubes (20EA); 20CM S.S. Implant Needles, 14 Degrees (20EA)

    FDA Recall
    Terminated ·Alpha Omega Services Inc·Product code JAQ·February 21, 2006

    GammaMed Plastic Needle with Mandrin; 2.0 mm diameter, length 320 mm. Remote controlled radionuclide applicator system. Varian Medical Systems, Inc. Mfg by Varian Medical Systems Haan GmbH, Haan, Germany. The interstitial plastic needles with 2 mm diameter are designed for interstitial treatments in areas such as head and neck, gynecology, breast or prostate. In order to avoid bending and to facilitate the introduction of the needles, each needle is supplied with a mandrin.

    FDA Recall
    Terminated ·Varian Medical Systems, Inc.·Product code JAQ·September 30, 2008

    EPROM and Control Software (embedded), version 5.08, for the GammaMed 12i/t Afterloader, manufactured by Varian Medical Systems, Inc, Palo Alto, CA 94304.

    FDA Recall
    Terminated ·Varian Medical Systems·Product code JAQ·February 6, 2004

    GammaWin software, part number GM11019110, versions up to and including 1.62, for the GammaMedplus 3/24 radionuclide applicator system, for radiation therapy.

    FDA Recall
    Terminated ·Varian Medical Systems·Product code JAQ·May 1, 2006

    Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium intrauterine probe with stopper length 40 mm, 30 degree angle. Varian Medical Systems, Palo Alto, CA; Manufactured by Varian Medical Systems Haan GmbH, Haan, Germany. To treat cancer of the uterus, cervix, endometrium and vagina.

    FDA Recall
    Terminated ·Varian Medical Systems, Inc. Oncology Systems·Product code JAQ·July 13, 2011

    Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium intrauterine probe with stopper length 30 mm, 30 degree angle. Varian Medical Systems, Palo Alto, CA; Manufactured by Varian Medical Systems Haan GmbH, Haan, Germany. To treat cancer of the uterus, cervix, endometrium and vagina.

    FDA Recall
    Terminated ·Varian Medical Systems, Inc. Oncology Systems·Product code JAQ·July 13, 2011

    Flexible Probe with Blocking Washer (part of Segmented Cylinder Set) The Segmented Cylinder Applicator Set was developed to treat cancer of the vagina, vaginal stump and rectum.

    FDA Recall
    Terminated ·Varian Medical Systems, Inc. Oncology Systems·Product code JAQ·July 13, 2011

    VariSource iX, Software Version 1.1, Part Number AL20020000 VariSource iX Afterloader. The VariSource iX Series High Dose Rate Afterloader system is a computer controlled remote electra/mechanical system used for medical purposes, for placing a NiTiNol wire incorporating an irradiated iridium seed internally or close by, a malignant tumor or tumor bed in a practice known as brachytherapy. The device has up to 20 channels for treatment.

    FDA Recall
    Terminated ·Varian Medical Systems, Inc.·Product code JAQ·March 1, 2010

    Varian brand GammaMed 12i Accessory: Clamping adapters for bronchial catheters, 1.8mm diameter, GammaMed 12i; Ref: BT-00264, Model 2-H63; Product is distributed by Varian Medical Systems Inc., Palo Alto, CA and Manufactured by Varian Medical Systems Haan GmbH, Bergische Strasse 16, D-42781 Haan, Germany. The Varian Medical System GammaMed Afterloader system is a remotely controlled intelligent robotic device intended to be used to deliver high dose-rate radiation therapy, in close proximity to and from within diseased tissues. Palliative care and treatments with curative intent to both benign and non-benign disease using interstitial, intracavitary, intraluminal, intra and inter-operative brachytherapy or combinations of any these treatment types are possible using this device.

    FDA Recall
    Terminated ·Varian Medical Systems, Inc. Oncology Systems·Product code JAQ·October 6, 2011

    GammaMed Flexible Applicator Probe, Part GM11002560 - 3.2 mm diameter braced PVDF. Varian Medical Systems, Palo Alto, CA, Mfg. by Varian Medical Systems, Haan GmbH. Designed for brachytherapy intracavity treatments in areas such as cancer of the vagina, vaginal stump or rectum.

    FDA Recall
    Terminated ·Varian Medical Systems, Inc.·Product code JAQ·August 5, 2008

    Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium intrauterine probe with stopper length 70 mm, 30 degree angle. Varian Medical Systems, Palo Alto, CA; Manufactured by Varian Medical Systems Haan GmbH, Haan, Germany. To treat cancer of the uterus, cervix, endometrium and vagina.

    FDA Recall
    Terminated ·Varian Medical Systems, Inc. Oncology Systems·Product code JAQ·July 13, 2011

    Nucletron Adapter and Transfer Guide Tube, part number AL 13005000, a component used with the VariSource" IX HDR Afterloader. Product Usage: The adapter is part of the VariSource Afterloader System, a computer controlled remote HDR Afterloader used to place a high activity radioactive source within a needle(s) or applicator(s) which have previously been placed for a specific clinical purpose in a patient.

    FDA Recall
    Terminated ·Varian Medical Systems, Inc.·Product code JAQ·January 5, 2012

    Nucletron Adapter and Transfer Guide Tube Set, part number AL 13005001, set of 3 adapters, components used with the VariSource" IX HDR Afterloader. Product Usage: The adapter is part of the VariSource Afterloader System, a computer controlled remote HDR Afterloader used to place a high activity radioactive source within a needle(s) or applicator(s) which have previously been placed for a specific clinical purpose in a patient.

    FDA Recall
    Terminated ·Varian Medical Systems, Inc.·Product code JAQ·January 5, 2012

    VariSource AL 13199024, Implant Tube, Implant Tube, Intralumenal(HDR), 10CM Drawdown 130CM Body, Sealed End, Cable Insert & Gold Seed, Disposable

    FDA Recall
    Terminated ·Alpha Omega Services Inc·Product code JAQ·February 21, 2006

    VariSource AL13198000, Intralumenal Kit

    FDA Recall
    Terminated ·Alpha Omega Services Inc·Product code JAQ·February 21, 2006