BEUDAMED
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    CODMAN RANEY SCALP CLIPS-Disposable cylindrical clips designed to provide hemostasis to the scalp wound edge. Part Number: 201037

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code HBO·June 1, 2021

    Thermo Scientific Microm: Rotary Microtome: REF HM355S-3 Used for slicing tissue blocks.

    FDA Recall
    Terminated ·Richard-Allan Scientific Company·Product code IDO·August 12, 2011

    ADVANSYS TTC, Model Numbers: 181011S, 181012S, 181013S, 181014S, 181001S, 181002S, 181003S & 181004S

    FDA Recall
    Terminated ·NewDeal SA Immeuble Sequoia·Product code HRS·May 22, 2018

    Codman ISOCOOL Bipolar Forceps-are indicated for cauterizing, coagulating, grasping, and manipulating tissue during general surgery, neurosurgery, ENT surgery, OB/GYN surgery, and maxillofacial / plastic surgery procedures. Model # 8145100S

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code GEI·July 19, 2019

    Integra Jarit GEMINI CLAMP 9 1/4 inch - used in vascular and cardiothoracic procedures used for clamping and occluding vessels. Cat. #140-332

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code DXC·August 7, 2019

    Integra Licox Pt02 Monitor, Rx Only, Manufacturer: Integra LifeSciences (Ireland) Limited, IDA Business and Technology Park, Sragh, Tullamore, County Offaly, Ireland, Distributed by: Integra LifeSciences Corporation, 311 Enterprise Drive, Plainsboro, NJ 08536

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code GWM·August 18, 2014

    Bactiseal Endoscopic Ventricular Catheter: EVC- Catheter is designed for use in the treatment of hydrocephalus when shunting cerebrospinal fluid (CSF) from the ventricles of the brain. Part Number: 823087

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code JXG·December 14, 2020

    ADVANSYS MLP/DLP, Model Numbers: 181051S, 181052S, 181041S, 181042S, 181031S, 181032S, 181033S, 181021S, 181022S & 181023S

    FDA Recall
    Terminated ·NewDeal SA Immeuble Sequoia·Product code HRS·May 22, 2018

    TIBIAXYS, Model Numbers: 150010S, 150020S, 150030S, 150040S, 150120S, 150110S, 150130S, 150200S, 150240S, 150242S, 150246S, 150250S, 150255S, 150260S, 150265S, 150270S, 150275S, 150280S, 150285S, 150290S, 150514S & 150516S

    FDA Recall
    Terminated ·NewDeal SA Immeuble Sequoia·Product code HRS·May 22, 2018

    UNI-CP, Model Numbers: 330021S, 330023S, 330025S, 330030S, 330025S, 30030S, 330217S, 330220S, 330225S, 330230S, 330420S, 330425S, & 330430S

    FDA Recall
    Terminated ·NewDeal SA Immeuble Sequoia·Product code HRS·May 22, 2018

    Bactiseal Ventricular Catheter with Bactiseal Shunt System - Product Usage: use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting cerebrospinal fluid (CSF) Part Number: 823073

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code JXG·December 14, 2020

    Large QWIX, Model Numbers: 111740S, 111745S, 111750S, 111755S, 111760S, 111765S, 111770S, 111775S, 111780S, 111785S, 111790S, 111795S, 111800S, 111805S, 111810S, 111815S, 111820S, 121740S, 121745S, 121750S, 121755S, 121760S, 121765S, 121770S, 121775S, 121780S, 121785S, 121790S, 121795S, 121800S, 121805S, 121810S, 121815S & 121820S

    FDA Recall
    Terminated ·NewDeal SA Immeuble Sequoia·Product code HRS·May 22, 2018

    CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal Catheter 120cm, with drainage Holes and Marking. For use in the treatment of hydrocephalus. Catalog Number: NS5524

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code HCA·March 17, 2021

    Universal Compact Head Ring Adapter Plate (UCHRAP), a component of the Universal Compact Head Ring Adapter, UCHRA. The UCHRA is a component of the Integra CRW Precision Arc Stereotactic System.

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code HAW·August 21, 2015

    Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 20 gauge x 5 inch. Plastic Hub, Metal Stylet, calibrations (10BX). Integra Long Epidural Steroid Injection Needle (Catalogue #PITRW2050). Peel Pouch. The Integra Long Epidural Steroid Injection Needle is packaged in a labeled and sterilized sealed tyvek / plastic pouch. The sterilized pouches are subsequently packaged in a case of 10 that is labeled, sealed and distributed to customers. Pain management procedure trays contain Tuohy Epidural Injection Needles to administer steroid medication in the epidural space. The needles are also available as an individually packaged single use, sterile device, as was the case with the affected lot in question.

    FDA Recall
    Terminated ·Integra LifeSciences Corp. d.b.a. Integra Pain Management·Product code BSP·May 1, 2015

    Integra External Fixation System Slotted Post - Small Catalogue #12224228; Integra External Fixation System Slotted Post Large Catalogue #12224229

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code KTT·July 20, 2016

    Composite Series Skull Clamp, one clamp per tote. The MAYFIELD Skull Clamp (A3059) is a cranial stabilization device, designed to provide rigid skeletal fixation. The Skull Clamp is placed on the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid skeletal fixation is necessary

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code HBL·August 29, 2013

    Integra External Fixation System Universal Wire Fixation Bolt - 17.5 mm Catalogue #12224218 ; Integra External Fixation System Universal Wire Fixation Bolt - 23 mm Catalogue #12224219

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code KTT·July 20, 2016

    Integra CUSA Excel Disposable Wrench. Catalog Number C5601. The CUSA Excel+ Sterile 23 kHz Torque Wrench is an accessory used with the CUSA Excel+ System ultrasonic surgical instrument. The torque wrench is used to properly secure the CUSA tip to the CUSA handpiece in the sterile field.

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code LFL·March 10, 2014

    Integra Camino Advanced Monitor with Waveform Display Model CAM01 Integra Neurosciences, 311 Enterprise Dr Plainsboro, NJ 08536 USA The Camino Advanced Monitor is a compact, portable device for use with Camino 110-4 series of Pressure / Temperature and Pressure Transducer-Tipped Catheters. Pressure and/or Temperature are measured at the Catheter tip, eliminating the need for external transducers, fluid, pressure tubing, and flush devices. The Camino displays intracranial pressure (ICP), intracranial temperature (ICT), and calculates cerebral perfusion pressure (CPP) (CPP = mean arterial pressure - mean intracranial pressure). The Camino provides a continuous display of the ICP waveform, as well as mean ICP, CPP, ICT, or systolic and diastolic waveform values. A continuous record of mean pressure and CPP values over the most recent 24-hour period is stored in memory, and can be displayed on command as a TREND either as the most recent 12 or 24 hour period. Outputs for ICP and ICT are available for use with patient bedside monitors. An isolated analogue output provides a continuous ICP waveform for hard copy documentation or data acquisition. An input to receive mean arterial pressure from a compatible patient bedside monitor is available for use when it is desired to have a CPP reading. The mean arterial pressure cannot be acquired from a non-invasive blood pressure cuff. Although the Camino is intended to be a stand-alone system, it also conveniently connects to hospital bedside monitoring systems.

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code GWM·November 26, 2013