BEUDAMED
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    Tri-State Hospital Supply Corp., Tri-State Centurion Port Access Trays, Qty/case 20, sterile, Code no./reorder DT9405B. Each tray contains 1 sterile heparin flush injection solution as follows: Tyco Healthcare Monoject Prefill100U/mL Heparin Lock Flush Syringe, 5mL, REF # 8881590125.

    FDA Recall
    Terminated ·Tri-State Hospital Supply Corporation·Product code OKE·April 8, 2008

    Tri-State Hospital Supply Corp., Tri-State Centurion Venous Access Port Kits, Qty/case 20, sterile, Code No./Reorder KNV80. Each kit contains 1 sterile heparin flush injection solution as follows: Tyco Healthcare Monoject Prefill 100U/mL Heparin Lock Flush Syringe, 10mL, REF # 8881590121.

    FDA Recall
    Terminated ·Tri-State Hospital Supply Corporation·Product code OKE·April 8, 2008

    Tri-State Hospital Supply Corp., Tri-State Centurion Port Blood Draw Trays, Qty/case 20, sterile, Code no./reorder DT9410B. Each tray contains 1 sterile heparin flush prefilled syringe as follows: Tyco Healthcare Monoject Prefill100U/mL Heparin Lock Flush Syringe, 5mL, REF # 8881590125.

    FDA Recall
    Terminated ·Tri-State Hospital Supply Corporation·Product code OKE·April 8, 2008

    Tri-State Hospital Supply Corp., Tri-State Centurion Port Access Trays, Qty/case 20, sterile, Code no./reorder KNV50. Each tray contains 1 sterile heparin flush injection solution as follows: Tyco Healthcare Monoject Prefill100U/mL Heparin Lock Flush Syringe, 5mL, REF # 8881590125.

    FDA Recall
    Terminated ·Tri-State Hospital Supply Corporation·Product code OKE·April 8, 2008

    Pointts sistema de ellmlnact!;o de verrugas OTC - Brazil Catalog Number: 1001-0280 - Product Usage: indicated for over-the-counter a cryosurgical system for the treatment of skin tags.

    FDA Enforcement
    Class III ·Terminated·OraSure Technologies, Inc.·September 30, 2020

    AdvanDx E. coli/P. aeruginosa PNA FISH Culture Identification Kit for the diagnosis of E. coli and/or P. aeruginosa bacteremia Catalog Number: KT007

    FDA Recall
    Terminated ·AdvanDx, Inc.·Product code JSS·October 6, 2010

    Pointts sistema de ellmlnact!;o de verrugas OTC - Brazil Catalog Number: 1001-0280 - Product Usage: indicated for over-the-counter a cryosurgical system for the treatment of skin tags.

    FDA Recall
    Terminated ·OraSure Technologies, Inc.·Product code GEH·July 15, 2020

    ZOLL Pro-padz Sterile Adult Multi-Function Electrodes Part number: 8900-4012 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation to a SAL of 1 o.e per International/ National Standards, EN ISO 11137- 2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring. These MFE electrodes have a 12 month shelf life from time of manufacture.

    FDA Enforcement
    Class II ·Terminated·Bio-Detek, Inc.·September 24, 2014

    ZOLL Pro-padz Sterile Adult Multi-Function Electrodes ((singles) Part number: 8900-4013 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation to a SAL of 1 o.e per International/ National Standards, EN ISO 11137- 2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring. These MFE electrodes have a 12 month shelf life from time of manufacture.

    FDA Enforcement
    Class II ·Terminated·Bio-Detek, Inc.·September 24, 2014

    King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.

    FDA Recall
    Terminated ·King Systems Corp.·Product code CAE·December 13, 0012

    diaDexus Inc. PLAC Test Reagent Kit, Turbidimetric Immunoassay for the Quantitative Determination of Lp-PLA2 in Human Plasma or Serum, liquid ready-to-use two-reagent kit assembled in a kit box, manufactured by diaDexus Inc, South San Francisco, CA 94080, Catalog number 90110 Turbidimetric Immunoassay for the Quantitative Determination of Lp-PLA2 in Human Plasma or Serum on automated clinical chemistry analyzers, to be used in conjunction with clinical evaluations and patient risk assessment as an aide in predicting risk for coronary heart disease, and ischemic stroke associated with atherosclerosis.

    FDA Recall
    Terminated ·DiaDexus, Inc·Product code NOE·November 4, 2008

    Cirugia Cardiovascular Case Cart, c ode 900-1415A, contains: (1) CIRUGIA CARDIOVASCULAR .(INDUCCION) (1) CIRUGIA CARDIOVASCULAR (CIRUGIA ) (1) CIRUGIA CARDIOVASCULAR (PREP ENFERMERA CIRCULANTE) (1) CIRUGIA CARDIOVASCULAR (PERFUSION SUPPLIES) (1) CIRUGIA CARDIOVASCULAR (POST- CIRUGIA) (1) OPEN HEART TRAY Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Enforcement
    Class I ·Terminated·Customed, Inc·September 10, 2014

    Cable remote control JUPITER, Material no. 4544119, Serial number: to (incl.) 102284378. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system.

    FDA Enforcement
    Class II ·Terminated·Trumpf Medical Systems, Inc.·January 14, 2015

    (R)Cable remote control JUPITER, Material no.1219655, Serial number: to (incl.) 101998119. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system.

    FDA Enforcement
    Class II ·Terminated·Trumpf Medical Systems, Inc.·January 14, 2015

    Cable remote control JUC, BUTTON, Material no.1239823, Serial number: to (incl.) 100143048. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system.

    FDA Enforcement
    Class II ·Terminated·Trumpf Medical Systems, Inc.·January 14, 2015

    (R)IR remote control JUPITER, Material no.1219656, Serial number: to (incl.) 102317869. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system.

    FDA Enforcement
    Class II ·Terminated·Trumpf Medical Systems, Inc.·January 14, 2015

    Cable remote control JUPITER / TS7500, Material no.1601926, Serial number: to (incl.) 101465919. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system.

    FDA Enforcement
    Class II ·Terminated·Trumpf Medical Systems, Inc.·January 14, 2015

    IR remote control JUC, BUTTON, Material no.1239824, Serial number: to (incl.) 100139854. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system.

    FDA Enforcement
    Class II ·Terminated·Trumpf Medical Systems, Inc.·January 14, 2015

    IR remote control JUPITER U, Material no. 4500120, Serial number: to (incl.) 102306940. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system.

    FDA Enforcement
    Class II ·Terminated·Trumpf Medical Systems, Inc.·January 14, 2015

    Cable remote control JUX Material, no.1307315, Serial number: to (incl.) 101287649. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system.

    FDA Enforcement
    Class II ·Terminated·Trumpf Medical Systems, Inc.·January 14, 2015