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    Guidant Contak Renewal 3 CRT-D Model H170; 3CRT-D, Model H175; 3HE CRT-D, Model H177; 3HE CRT-D, Model H179; 4CRT-D REF H190; 4CRT-D REF H195; 4HE CRT-D REF H197; 4HE CRT-D REF H199; 4AVT CRT D, REF M177; 4AVT HE CRT-D REF 179. Cardiac Resynchronization Therapy Defibrillator, Sterile EO, Guidant Corporation, 4100 Hamline Avenue North, St Paul, MN 55112-5798. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Recall
    Terminated ·Boston Scientific CRM Corp·Product code LWP·March 4, 2009

    Guidant CONTAK RENEWAL 3 (Models H170, H173, H175), Guidant CONTAK RENEWAL 3 HE (Models H177, H179). Guidant CONTAK RENEWAL 4 (Models H190,H195) *, Guidant CONTAK RENEWAL 4 HE (Models H197, H199)* Cardiac Resynchronization Therapy Defibrillator (CRT-D). Sterile EO. Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. (* models are not available in the USA).

    FDA Recall
    Terminated ·Boston Scientific CRM Corp·Product code LWP·March 16, 2007

    Guidant CONTAK RENEWAL 3 (models H170, H173, H175), CONTAK RENEWAL 3 HE (models H177, H179) CONTAK RENEWAL 4 (models H190, H195), CONTAK RENEWAL 4 HE (models H197, H199). Cardiac Resynchronization Therapy Defibrillator (CRT-D). Sterile EO. Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Cardiac resynchronization therapy defibrillators (CRT-D) provide ventricular tachyarrhythmia and cardiac resynchronization therapies. Ventricular tachyarrhythmia therapy is for the treatment of ventricular tachycardia (VT) and ventricular fibrillation (VF), rhythms that are associated with sudden cardiac death (SCD). Cardiac resynchronization therapy is for the treatment of heart failure (HF) and uses biventricular electrical stimulation to synchronize ventricular contractions. Cardioversion/defibrillation therapies include a range of low- and high-energy shocks using either a biphasic or monophasic waveform.

    FDA Recall
    Terminated ·Guidant Corporation·Product code NIK·May 15, 2006

    VITROS Chemistry Products CHE Slides packaged as 300 slides/pack catalog number 1914605 and packaged as 90 slides/pack catalog number 8004707 VITROS CHE Slides quantitatively measure cholinesterase (CHE) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics·November 27, 2013

    Dialog+ Hemodialysis machines: Dialog A + HE/BIC Product Code 710200L Serial # >200318 and < 2039222 The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis and low flux hemodialysis.

    FDA Enforcement
    Class I ·Terminated·B Braun Medical Inc·May 11, 2016

    CONTAK RENEWAL 3 (model H170, H175) CONTAK RENEWAL 3 HE (model H177, H179) Cardiac Resynchronization Therapy Defibrillator (CRT-D). Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA.

    FDA Recall
    Terminated ·Boston Scientific CRM Corp·Product code NIK·March 23, 2007

    These models are not available in the US. CONTAK RENEWAL 4 (model H190, H195). CONTAK RENEWAL 4 HE (model H197, H199) Cardiac Resynchronization Therapy Defibrillator (CRT-D). Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA.

    FDA Recall
    Terminated ·Boston Scientific CRM Corp·Product code NIK·March 23, 2007

    CONTAK RENEWAL 3 CRT-D (model no. H170, H173, H175) and CONTAK RENEWAL 3 HE CRT-D(model no. H177 and H179). Cardiac Resynchronization Therapy Defibrillator. Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 5511-5798 USA. CONTAK RENEWAL 3 devices provide ventricular tachyarrhythmia and cardiac resynchronization therapies.

    FDA Recall
    Terminated ·Guidant Corporation·Product code NIK·June 24, 2005

    CONTAK RENEWAL 4 CRT-D (model no. H190 and H195) and CONTAK RENEWAL 4 HE CRT-D (model no. H197 and H199). Cardiac Resynchronization Therapy Defibrillator. Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 5511-5798 USA. CONTAK RENEWAL 4 devices provide ventricular tachyarrhythmia and cardiac resynchronization therapies.

    FDA Recall
    Terminated ·Guidant Corporation·Product code NIK·June 24, 2005

    Guidant CONTAK RENEWAL 3 (models H170,H175) CONTAK RENEWAL 3 HE (models H177, H179) Cardiac Resynchronization Therapy Defibrillator (CRT-D). Sterile EO. Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Cardiac resynchronization therapy defibrillators (CRT-D) provide ventricular tachyarrhythmia and cardiac resynchronization therapies. Ventricular tachyarrhythmia therapy is for the treatment of ventricular tachycardia (VT) and ventricular fibrillation (VF), rhythms that are associated with sudden cardiac death (SCD). Cardiac resynchronization therapy is for the treatment of heart failure (HF) and uses biventricular electrical stimulation to synchronize ventricular contractions. Cardioversion/defibrillation therapies include a range of low-and high-energy shocks using either a biphasic or monophasic waveform.

    FDA Recall
    Terminated ·Guidant Corporation·Product code NIK·April 7, 2006

    Dialog+ Hemodialysis machines: Dialog A + HE/BIC Product Code 710200L Serial # >200318 and < 2039222 The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis and low flux hemodialysis.

    FDA Recall
    Terminated ·B Braun Medical Inc·Product code KDI·April 1, 2016

    Guidant CONTAK RENEWAL 4 (models H190, H195) CONTAK RENEWAL; 4 HE (model H197). Cardiac Resynchronization Therapy Defibrillator (CRT-D). Sterile EO. Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Cardiac resynchronization therapy defibrillators (CRT-D) provide ventricular tachyarrhythmia and cardiac resynchronization therapies. Ventricular tachyarrhythmia therapy is for the treatment of ventricular tachycardia (VT) and ventricular fibrillation (VF), rhythms that are associated with sudden cardiac death (SCD). Cardiac resynchronization therapy is for the treatment of heart failure (HF) and uses biventricular electrical stimulation to synchronize ventricular contractions. Cardioversion/defibrillation therapies include a range of low-and high-energy shocks using either a biphasic or monophasic waveform.

    FDA Recall
    Terminated ·Guidant Corporation·Product code NIK·April 7, 2006

    Guidant CONTAK RENEWAL 3 (models H170, H175) CONTAK RENEWAL 3 HE (models H177, H179) Cardiac Resynchronization Therapy Defibrillator (CRT-D). Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Cardiac resynchronization therapy defibrillators (CRT-D) provide ventricular tachyarrhythmia and cardiac resynchronization therapies. Ventricular tachyarrhythmia therapy is for the treatment of ventricular tachycardia (VT) and ventricular fibrillation (VF), rhythms that are associated with sudden cardiac death (SCD). Cardiac resynchronization therapy is for the treatment of heart failure (HF) and uses biventricular electrical stimulation to synchronize ventricular contractions. Cardioversion/defibrillation therapies include a range of low-and high-energy shocks using either a biphasic or monophasic waveform.

    FDA Recall
    Terminated ·Boston Scientific CRM Corp·Product code NIK·May 15, 2006

    CONTAK RENEWAL 3 (Models H170), Guidant CONTAK RENEWAL 3 HE (Models H177, H179). Cardiac Resynchronization Therapy Defibrillator (CRT-D). These CRT-Ds provide ventricular tachyarrhythmia and cardiac resynchronization therapies. Ventricular tachyarrhythmia therapy is for the treatment of ventricular tachycardia (VT) and ventricular fibrillation (VF), rhythms that are associated with sudden cardiac death (SCD). Cardiac resynchronization therapy is for the treatment of heart failure (HF) and uses biventricular electrical stimulation to synchronize ventricular contractions. Cardioversion/defibrillation therapies include a range of low- and high-energy shocks using either a biphasic or monophasic waveform. Sterile EO. Boston Scientific Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA.

    FDA Recall
    Terminated ·Boston Scientific CRM Corp·Product code NIK·March 15, 2010

    SYNCHRON Systems Vancomycin Reagent, in vitro diagnostic. Part Number 474824.

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code LEH·March 30, 2006

    INSURE(R) QUIK FIT(TM) DEVELOPER KIT, Lot number B1478, Product Numbers: 30025 (InSure Quik FIT Developer Kit) and 50025 (INSURE(R) QUIK FIT(TM) containing Developer Kit and Patient Collection Kits. Product Number 30025 - InSure(R) Quik FIT)TM) Developer Kit (1 Box) . Each box contains: 25 InSure(R) Quik FIT(TM) Test Strips (1 per foil pack), 1 InSure(R) Quik FIT(TM) Conjugate Solution, I InSure(R) Quik FIT(TM) Run Buffer, and 1 InSure(R) Quik FIT(TM) Product Instructions. Product 50025 - InSure(R) Quik FIT(TM) contains 25 Patient Kits & 1 Developer Kit.

    FDA Recall
    Terminated ·Enterix, Inc.·Product code KHE·October 3, 2008

    Clearview iFOB, Clearview - Sample Kit (5 Test)Immunochemical Fecal Occult Blood Cassette Test Product Part Number: 8112KCV (5 Test Kit ), Intended Use: Immunochemical device intended for the qualitative detection if fecal occult blood in human feces by laboratories or physician offices

    FDA Recall
    Terminated ·Alere North Americal 30 S Keller Rd Ste 100 Suite 100 Orlando FL 32810-6297·Product code KHE·March 21, 2011

    Regard, Item Number 830054001, CV00625A - OPEN HEART A&B - Custom surgical kit for cardiovascular surgery.

    FDA Recall
    Terminated ·Resource Optimization & Innovation Llc·Product code LHC·August 25, 2015

    VITROS Chemistry Products VANC Reagent, REF/Product Code 680 1709, Unique Identifier No. 10758750006731, Rx ONLY, IVD --- Ortho Clinical Diagnostics - USA -- Ortho-Clinical Diagnostics Pencoed, CF35 5PZ, UK ---- The VITROS VANC reagent is for ORTHO Clinical Diagnostics manufactured by Siemens. The VANC product has a maximum on-analyzer stability of < 7days. The on-analyzer stability of each VITROS VANC Reagent pack is determined by the system. Once the VANC reagent pack is loaded on the system, the on-analyzer stability time is continuously adjusted based upon both the amount of time the reagent pack is on the analyzer and the number of tests remaining in the pack. The method by which the on-analyzer stability of the VITROS VANC Reagent is determined is stated in the reagents Instructions for Use.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code LEH·February 21, 2017

    Clearview iFOB, Clearview iFOB Complete- Immunochemical Fecal Occult Blood Cassette Test Product Part Number: 8111KCV (30 Test Kit ), Intended Use: Immunochemical device intended for the qualitative detection if fecal occult blood in human feces by laboratories or physician offices

    FDA Recall
    Terminated ·Alere North Americal 30 S Keller Rd Ste 100 Suite 100 Orlando FL 32810-6297·Product code KHE·March 21, 2011