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This page shows you the most recent publications within this specialty of the MedWorm directory. This is page number 27.

Advanced Sterilization Products - STERRAD Cyclesure Biological Indicator (BI), - Class 2 Recall
STERRAD Cyclesure Biological Indicator (BI), P/N 14324 are sold in cases, packaged as part of STERRAD System Validation kits and STERRAD test packs. The STERRAD CYCLESURE 24 Biological Indicator (BI), P/N 14324 is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.
Source: Medical Device Recalls - July 27, 2012 Category: Medical Equipment Source Type: alerts

Getinge USA Inc - Class 2 Recall
Getinge brand --- large capacity, floor loading jet spray, washers for mechanical washing, intermediate level, thermal disinfection and drying of moisture and temperature stable Hospital case carts, sterilization containers, material handling carts, stands and utensils. --- Model numbers Getinge 9120, 9122, 9125, and 9128
Source: Medical Device Recalls - July 26, 2012 Category: Medical Equipment Source Type: alerts

Tripath Imaging, Inc. - PrepStain System - Class 2 Recall
PrepStain PM Kit, T-AG (Catalog 490588); PrepStain PM Kit Europe (Catalog 490671); PrepStain Prep Only PM Kit, T-AG (Catalog 490954); PrepStain PM Kit XLP, T-US-II (Catalog 490424); PrepStain Prep PM Kit XLP T-US-II (Catalog 491118); PrepStain Prep Only PM Kit XLP, T-US-II (490423); PrepStain Prep Only PM Kit, T-US (Catalog 490429); PrepStain PM Kit, T-US (Catalog 490626); PrepStain PM Kit Europe, T-US (Catalog 490428). The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produces SurePath Slides that are intended for use in the screening and detection of cervical cancer, pre-ca...
Source: Medical Device Recalls - July 26, 2012 Category: Medical Equipment Source Type: alerts

Stryker Howmedica Osteonics Corp. - ABG II Modular Hip Stem - Class 2 Recall
ABG II Modular Hip Stem Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430 Stryker Ireland Carrigtwohill Industrial Estate, Carrigtwohill County Cork, Ireland. The ABG II Modular range of implants is constituted of 8 right stems and 8 left stems. The necks are made of GADS Vitallium, a proprietary Co Cr alloy that Stryker has developed. GADS stands for Gas Atomized Dispersion Strengthened. IT is a Co Cr alloy that is a corrosion resistant and demonstrates qualities of improved fatigue strength (with respect to regular Co Cr alloy). Neck Range - The ABG II modular neck range is composed of 10 reversible neck implants. Ther...
Source: Medical Device Recalls - July 26, 2012 Category: Medical Equipment Source Type: alerts

Tripath Imaging, Inc. - PrepStain System - Class 2 Recall
PrepStain Upgrade Kit: 1.3.0.3/1.2 DiTi Cone. The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produces SurePath Slides that are intended for use in the screening and detection of cervical cancer, pre-cancerous lesions, atypical cells and all other cytologic categories as defined by The Bethesda System for Reporting Cervical/Vaginal Cytology Diagnoses. The 1.2 DiTi is the tip on the PrepStain to which a pipette tip attaches and dispenses patient samples onto a glass microscope slide.
Source: Medical Device Recalls - July 26, 2012 Category: Medical Equipment Source Type: alerts

Stryker Howmedica Osteonics Corp. - Rejuvenate Modular Stems - Class 2 Recall
Rejuvenate Modular Stems Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork, Ireland Rejuvenate Modular Necks Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430. Stem Bodies Rejuvenate Modular consists of 6 modular stems bodies in sizes 7-12. The Modular Stem bodies are made of TMZF alloy, developed specifically for orthopaedic applications. Rejuvenate Modular Necks The Rejuvenate Modular Necks are made of Cobalt Chrome. The necks in this system consist of 4 lengths in 4 mm increments. They are 30 mm, 34 mm, 38 mm and 42 mm. They come in multiple neck angles and versions in each length. They are 1...
Source: Medical Device Recalls - July 26, 2012 Category: Medical Equipment Source Type: alerts

Hill-Rom, Inc. - Affinity Four Birthing Bed P3700 - Class 2 Recall
Affinity Four Birthing Bed P3700 Product Usage: The Affinity, Four Birthing Bed is intended to be used as birthing beds for women of child bearing age in an LDR (Labor, Delivery, Recovery ) or LDRP (Labor, Delivery, Recovery, Postpartum) setting within the acute care Labor and Delivery market. They are not intended for use as general hospital beds.
Source: Medical Device Recalls - July 26, 2012 Category: Medical Equipment Source Type: alerts

CareFusion 303, Inc. - Alaris PC unit - Class 1 Recall
Alaris PC unit model 8015 Product Usage: The device is labeled for prescription use only.
Source: Medical Device Recalls - July 26, 2012 Category: Medical Equipment Source Type: alerts

Philips And Neusoft Medical Systems Co., Ltd. - NeuViz 16 MultiSlice CT Scanner System - Class 2 Recall
NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a Part number 989605858501. The device is labeled in part: "***Neusoft***NeuViz16 MULTI-SLICE CT SCANNER SYSTEM***MANUFACTURED FOR NEUSOFT MEDICAL SYSTEMS CO., LTD***MANUFACTURED BY PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO., LTD***ADDRESS: NEUSOFT PARK, HUNNAN INDUSTRIAL AREA, SHENYANG***CHINA***".
Source: Medical Device Recalls - July 26, 2012 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc - Siemens syngo.plaza - Class 2 Recall
Siemens syngo.plaza. Radiological image processing system
Source: Medical Device Recalls - July 26, 2012 Category: Medical Equipment Source Type: alerts

Stryker Howmedica Osteonics Corp. - Class 2 Recall
Tibial Punch Tower Assembly. Non-Sterile. CAT NO. 8000-1089. Howmedica Osteonics Corp., 59 Route 17, Allendale, NJ 07401. During primary Scorpio TKA procedures, the Scorpio Tibial Punch Tower (8000-1089) is used in conjunction with Scorpio Tibial Keel Punches (3760-0305/-0709/-1113 and 3761-0305/-0709/-1113) and Tibial Templates (3750-0003/-0005/-0007/-0009/-0013) to prepare the tibia for baseplate implantation. Per the surgical protocol for Duracon and Scorpio Total Knee Systems with Xcelerate Instrumentation (LSPK31 03/03), tibial templates are used to determine the appropriate coverage of the tibial plateau. Once a te...
Source: Medical Device Recalls - July 26, 2012 Category: Medical Equipment Source Type: alerts

Mallinckrodt Inc - P/N 302050 HANDI FIL DISPOSABLE SYRINGE FILL TUBE - Class 2 Recall
The Handi-Fil Disposable Syringe Fill Tube is a sterile plastic tube, approximately 10 inches in length, with a "J" shaped curve that projects upward approximately two inches. The Handi-Fil Disposable Syringe Fill Tube is used to transfer radiographic contrast media from a sterile vial to an injection syringe.
Source: Medical Device Recalls - July 26, 2012 Category: Medical Equipment Source Type: alerts

Hospira Inc. - Hospira LifeShield LatexFree 100 mL Burette Set - Class 2 Recall
Hospira LifeShield Latex-Free 100 mL Burette Set, Convertible Pin, 77 inch with 2 Prepierced Injection Sites and Option-Lok Microdrip Soluset with Calibrated Burette and Precision Drip Chamber; an Rx sterile medical device used to administer fluids; 20 individually wrapped sets per case; Made in Costa Rica, Hospira, Inc., Lake Forest, IL 60045 USA; list 12722-65. Intended use: for the administration of fluids.
Source: Medical Device Recalls - July 25, 2012 Category: Medical Equipment Source Type: alerts

The Anspach Effort, Inc. - Anspach Single Use, Sterile Bone Cutting Burrs (Model SHD4820DS) - Class 2 Recall
.***ANSPACH***Sterile. REF SHD-4820DS***QTY: 1, 4.8 mm x 2mm Twist Drill with Depth Stop. Use with SHORT-HD Attachment ***RX Only Product Usage: Cutting and shaping bone including bones of the spine and cranium.
Source: Medical Device Recalls - July 25, 2012 Category: Medical Equipment Source Type: alerts

GE OEC Medical Systems, Inc - GE OEC 9800 - Class 1 Recall
OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.
Source: Medical Device Recalls - July 24, 2012 Category: Medical Equipment Source Type: alerts

GE OEC Medical Systems, Inc - OEC 8800 Flexview, - Class 1 Recall
OEC 8800 Flexview, 892.1650 Image-intensified fluoroscopic x-ray system Product Usage: The 8800 Flexview is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures. Clinical applications may include cholangiography, urologic, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician s discretion.
Source: Medical Device Recalls - July 24, 2012 Category: Medical Equipment Source Type: alerts

AGFA Corp. - IMPAX CV Reporting NonInvasive Vascular (NIV)/Results Management (RM) NIV - Class 2 Recall
IMPAX CV Reporting The Results Management (RM)/IMPAX CV reporting component facilitates the quick, effective creating of digital structured reports for : adult catheterization and echocardiography, pediatric echocardiography, congenital heat disease, nuclear cardiology and non-invasive vascular disease management. This webb-based application allows cardiology departments to view, edit and sign the structured reports.
Source: Medical Device Recalls - July 24, 2012 Category: Medical Equipment Source Type: alerts

Bridgepoint Medical - Stingray Catheter - Class 2 Recall
BridgePoint Medical, Stingray Catheter, REF M - 1000, Sterilized with Ethylene Oxide Gas, Prescription Only, Manufacturer BridgePoint Medical Inc. 13355 10th Ave N, Suite 110, Plymouth, MN 55441. Stingray" Catheters are intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic coronary lesions (including chronic total occlusions) prior to PTCA or stent intervention. When used as part of the BridgePoint Medical System, the Stingray Catheter is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic coronary lesions (including chronic total occlusi...
Source: Medical Device Recalls - July 24, 2012 Category: Medical Equipment Source Type: alerts

GE OEC Medical Systems, Inc - OEC 6800 Miniview - Class 1 Recall
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
Source: Medical Device Recalls - July 24, 2012 Category: Medical Equipment Source Type: alerts

Exactech, Inc. - OPTETRAK RBKTIBIAL TRAY - Class 2 Recall
Product is labeled in part: "***OPTETRAK RBK***TIBIAL TRAY***FINNED, CEMENTED***CoCr Alloy***SIZE 2F/1T***REF 260-04-21***Exactech Gainesville, FL 32653-1630***. The Exactech Optetrak RBK Total Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for knee pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders and/or avascular necrosis of the femoral condyle, post-traumatic loss of the joint configuration (particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Additionally, the Optetr...
Source: Medical Device Recalls - July 24, 2012 Category: Medical Equipment Source Type: alerts

Exactech, Inc. - OPTETRAKTIBIAL TRAY - Class 2 Recall
Product is labeled in part: "***OPTETRAK***TIBIAL TRAY***TRAPEZOID CEMENTED***Ti Alloy*** SIZE 1F/1T, 2F/1T***FOR CEMENTED USE ONLY***Exactech, Gainesville, FL 32653-1630.***REF 204-04-21***". The Optetrak Comprehensive Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. In the USA, the Optetrak Comprehen...
Source: Medical Device Recalls - July 24, 2012 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc - ARTISTE or ONCOR Digital Linear Accelerators with syngo RT Therapist - Class 2 Recall
ARTISTE or ONCOR Digital Linear Accelerators with syngo RT Therapist version 4.2/MOSAIQ OIS Systems and Multiple-X, Manufactured by SIEMENS AG. The ARTISTE and ONCOR family of Linear Accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
Source: Medical Device Recalls - July 24, 2012 Category: Medical Equipment Source Type: alerts

Respironics, Inc. - Respironics Trilogy 100, 200, and 202 Ventilators - Class 1 Recall
Respironics Trilogy 100, 200, and 202 Ventilators The Respironics Trilogy systems provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Trilogy 100 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The devices are intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. They are not intended to be used as a transport ventilator.
Source: Medical Device Recalls - July 23, 2012 Category: Medical Equipment Source Type: alerts

Synthes USA HQ, Inc. - 4.5mm TI Multiloc Screw Length 28MM - Class 2 Recall
4.5mm TI Multiloc Screw Length 28MM-Sterile Expiration: 04/29/2012 REF 04.019.028S Manufactured or Distributed by Synthes (USA) 1101 Synthes Avenue, Monument CO 80132 4.5MM TI Multiloc Screw Length 28MM-Sterile Ref 04.019,038S. The Multiloc Screw 4.5 is used with a Multiloc PHN for treatment of proximal humerus fractures and is intended to be inserted through the Multiloc PHN until it engages the subchondral bone below the relative distal cortex (cortex closest to the humeral head, below the articular surface).
Source: Medical Device Recalls - July 23, 2012 Category: Medical Equipment Source Type: alerts

Ortho-Clinical Diagnostics - VITROS 4600 Chemistry System Software - Class 2 Recall
VITROS 4600 Chemistry System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest.
Source: Medical Device Recalls - July 23, 2012 Category: Medical Equipment Source Type: alerts

Ortho-Clinical Diagnostics - VITROS 5,1 FS System Software - Class 2 Recall
VITROS 5,1 FS System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest.
Source: Medical Device Recalls - July 23, 2012 Category: Medical Equipment Source Type: alerts

Ortho-Clinical Diagnostics - VITROS 5600 Integrated System Software - Class 2 Recall
VITROS 5600 Integrated System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest.
Source: Medical Device Recalls - July 23, 2012 Category: Medical Equipment Source Type: alerts

Synthes USA HQ, Inc. - 4.5mm TI Multiloc Screw Length 38MM - Class 2 Recall
4.5mm TI Multiloc Screw Length 38MM-Sterile Expiration: 04/29/2012 REF 04.019.038S Manufactured or Distributed by Synthes (USA) 1101 Synthes Avenue, Monument CO 80132 4.5MM TI Multiloc Screw Length 38MM-Sterile Ref 04.019,038S. The Multiloc Screw 4.5 is used with a Multiloc PHN for treatment of proximal humerus fractures and is intended to be inserted through the Multiloc PHN until it engages the subchondral bone below the relative distal cortex (cortex closest to the humeral head, below the articular surface).
Source: Medical Device Recalls - July 23, 2012 Category: Medical Equipment Source Type: alerts

Westone Laboratories, Inc. - OTO EASE - Class 2 Recall
Oto Ease by Westone, labeled as a bacteria free, greaseless lubricant. Sold in 0.5 oz consumer sized semi transparent flexible plastic bottles. Product Usage: The product is used as a patient lubricant which eases insertion of earmolds and hearing instruments such as hearing aids.
Source: Medical Device Recalls - July 20, 2012 Category: Medical Equipment Source Type: alerts

Leica Microsystems, Inc. - Leica M525 F50 surgical microscope - Class 2 Recall
Leica M525 F50 Surgical Microscope; Article No. 10338422; Product Usage: The intended use of this device is for improving visibility of objects through magnification and illumination. It can be applied for observation and documentation and for human and veterinary medical treatment.
Source: Medical Device Recalls - July 20, 2012 Category: Medical Equipment Source Type: alerts

Synthes USA HQ, Inc. - Universal Spinal System Lamina Hooks - Class 2 Recall
Universal Spinal System Lamina Hooks Synthes Medium TI Lamina Hook - Right 498.320 Non sterile LOT 6876785 Noncervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Limited to skeletally mature patients with the exception of the small stature USS, which includes small stature and pediatric patients. These devices are indicated as an adjunct to fusion for all of these indications: degenerative disc disease, spondylolisthesis, trauma, deformities or curvatures, tumor, stenosis and failed previous fusion.
Source: Medical Device Recalls - July 20, 2012 Category: Medical Equipment Source Type: alerts

OrthoPediatrics Corp - OrthoPediatrics Pediloc Locking Plate System - Class 2 Recall
OrthoPediatrics PediLoc Locking Plate System, 4.5mm Contour Locking Compression Femur 8 Hole Plate Right. Used for pediatric patients as indicated for pelvic, small and long bone fractures.
Source: Medical Device Recalls - July 20, 2012 Category: Medical Equipment Source Type: alerts

Terumo Cardiovascular Systems Corporation - The Terumo Advanced Perfusion System - Class 2 Recall
System 1 Base 100/120V The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
Source: Medical Device Recalls - July 20, 2012 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - GE Healthcare Optima Mobile Xray System - Class 2 Recall
GE Healthcare Optima Mobile X-ray System. The GE Automatic Mobile X-Ray (AMX ) Series are intended to take exposures utilizing film or computed radiography ( CR )
Source: Medical Device Recalls - July 19, 2012 Category: Medical Equipment Source Type: alerts

Stryker Spine - Stryker AVS Navigator - Class 2 Recall
Stryker AVS Navigator Trials 6mm-15mm Manufactured by: Stryker Spine SAS Z.1 Marticot-33610-Cestas -France +33 (0) 5.57.97.06.30 http;//www.stryker.com Distributed in the USA by Stryker Spine 2 Pearl Court. Allendale NJ 07401-1677 USA +1-201-780-8000 Cestas France 33610. Intended Use: The trials are designed and intended to measure the height of the disc space intra-operatively.
Source: Medical Device Recalls - July 19, 2012 Category: Medical Equipment Source Type: alerts

Hitachi Medical Systems America Inc - Hitachi Scenaria CT System Software - Class 2 Recall
Hitachi Scenaria CT System Software Product Usage: The Scenaria system is indicated to acquire axial volumes of the whole body including the head. The images can be acquired in either axial, helical, gated or dynamic modes. The volume datasets acquired by the Scenaria can be post processed by the Scenaria to provide additional information. Post processing capabilities included in the Scenaria software include CT angiography (CTA), Multi-planar reconstruction (MPR) and volume rendering.
Source: Medical Device Recalls - July 19, 2012 Category: Medical Equipment Source Type: alerts

Philips Medical Systems (Cleveland) Inc - Brilliance CT 6slice,16slice, 40channel, 64channel,Big Bore Oncology & Brilliance iCT and iCT SP - Class 2 Recall
Philips Brilliance 6, 16, 40, 64, Big Bore, iCT and iCT SP are Computed Tomography X-Ray Systems. The devices are Computed Tomography Systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes
Source: Medical Device Recalls - July 19, 2012 Category: Medical Equipment Source Type: alerts

Varian Medical Systems, Inc. Oncology Systems - Eclipse Treatment Planning System - Class 2 Recall
Varian brand Varian Eclipse Treatment Planning System for radiotherapy; Model Number: H48; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.
Source: Medical Device Recalls - July 19, 2012 Category: Medical Equipment Source Type: alerts

Alere San Diego, Inc. - Alere Triage ToxMTD Drug Screen - Class 2 Recall
Alere Triage Tox+MTD Drug Screen, PN 94400 Product Usage: The Alere Triage TOX Drug Screen is a fluorescence immunoassay to be used with the Alere Triage Meters for the qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, THC and tricyclic antidepressants in urine. The acetaminophen/paracetamol assay will yield positive results when acetaminophen/paracetamol is ingested at or...
Source: Medical Device Recalls - July 19, 2012 Category: Medical Equipment Source Type: alerts

Teleflex Medical - Hudson RCI Concha Therm Neptune Humidifier - Class 2 Recall
Hudson RCI Concha Therm Neptune Humidifier, Rx Only, Product Usage: Usage: Device that is intended to add moisture to, and sometime to warm, the breathing gases for administration to a patient.
Source: Medical Device Recalls - July 19, 2012 Category: Medical Equipment Source Type: alerts

Terumo Cardiovascular Systems Corporation - Sarns Modular Perfusion System 8000 - Class 2 Recall
Sarns Modular Perfusion System 8000 base, 4 pump 220/240V. The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
Source: Medical Device Recalls - July 19, 2012 Category: Medical Equipment Source Type: alerts

Terumo Cardiovascular Systems Corporation - Sarns Modular Perfusion System 9000 - Class 2 Recall
Sarns Modular Perfusion System 9000, 220/240V with color screen. The Sarns Perfusion System 9000 is indicated for use as a heart-lung system for pumping blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment.
Source: Medical Device Recalls - July 19, 2012 Category: Medical Equipment Source Type: alerts

Terumo Cardiovascular Systems Corporation - Sarns Modular Perfusion System 8000 - Class 2 Recall
Sarns Modular Perfusion System 8000 base, 5 pump 220/240V. The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
Source: Medical Device Recalls - July 19, 2012 Category: Medical Equipment Source Type: alerts

Terumo Cardiovascular Systems Corporation - Terumo Advanced Perfusion System 1 - Class 2 Recall
Terumo Advanced Perfusion System 1. System 1 base 220/240V. The Terumo Advanced Perfusion System I is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only When used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment.
Source: Medical Device Recalls - July 19, 2012 Category: Medical Equipment Source Type: alerts

Terumo Cardiovascular Systems Corporation - Sarns Modular Perfusion System 8000 - Class 2 Recall
Sarns Modular Perfusion System 8000 base, 4 pump 115V. The Sarns Modular Perfusion system 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
Source: Medical Device Recalls - July 19, 2012 Category: Medical Equipment Source Type: alerts

Epocal Inc - epoc Blood Analysis BGEM Test Cards - Class 2 Recall
epoc Blood Analysis BGEM Test Cards for use with the epoc(R) Blood Analysis System Product Usage: Usage: epoc Blood Analysis BGEM Test Cards are used with the epoc(R) Blood Analysis System which is a POC testing system
Source: Medical Device Recalls - July 19, 2012 Category: Medical Equipment Source Type: alerts

Terumo Cardiovascular Systems Corporation - Sarns Modular Perfusion System 8000 - Class 2 Recall
Sarns Modular Perfusion System 8000 base, 5 pump 115V. The Sarns Modular Perfusion Systern 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
Source: Medical Device Recalls - July 19, 2012 Category: Medical Equipment Source Type: alerts