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Corrective action for the MiniMed Silhouette™ and Sure-T™ infusion sets, Medtronic PDF, 378KB, File does not meet accessibility standards Date: 07. November 2014 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 07302/14

Recall for the Persona Stemmed 5 Degree Cemented Tibia, various sizes, Zimmer PDF, 49KB, File does not meet accessibility standards Date: 07. November 2014 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 07321/14

Recall for the Hercules™ 360 Universal Stabilizing Arm, Terumo Europe NV PDF, 81KB, File does not meet accessibility standards Date: 07. November 2014 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - cardiac/thorax surgery
Reference 07027/14

Corrective action for the Wilkins Chalgren Broth + NAD, heipha Dr. Müller GmbH PDF, 834KB, File does not meet accessibility standards Date: 04. November 2014 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 06976/14

Corrective action for the product LIAISON® Biotrin Parvovirus B19 IgM, DiaSorin S.p.A. PDF, 546KB, File does not meet accessibility standards Date: 04. November 2014 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 04894/14

Corrective action for the product NEFA FS, DiaSys Diagnostic Systems GmbH PDF, 18KB, File does not meet accessibility standards Date: 04. November 2014 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 06926/14

Corrective action for IMMULITE Calcitonin Control Module, Siemens Healthcare Diagnostics PDF, 123KB, File does not meet accessibility standards Date: 04. November 2014 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 07188/14

Recall of Double Lumen Needles for Oocyte Retrieval, Origio A/S PDF, 929KB, File does not meet accessibility standards Date: 04. November 2014 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - syringes and cannulas
Reference 06260/14

Corrective action for the THERMOCOOL® SMARTTOUCH® Catheter Family, Biosense Webster PDF, 230KB, File does not meet accessibility standards Date: 04. November 2014 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 06925/14

Follow-up Information for the Cadisc®-L Total Disc Replacement Device, RANIER PDF, 168KB, File does not meet accessibility standards Date: 03. November 2014 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 01923/14

Recall for the products DERESON® (GIRO) AF, ENDES AF, ULTRADESMIT® AF and BOHRTAN® AF, esteer Pharma GmbH PDF, 133KB, File does not meet accessibility standards Date: 03. November 2014 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - cleaning / disinfection / sterilisation
Reference 07141/14

Corrective action for the Prismaflex® control unit used together with the PrismaLung™ Kit, Gambro PDF, 982KB, File does not meet accessibility standards Date: 03. November 2014 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - dialysis technology
Reference 06909/14

Corrective action for the product Relief ACP Oral Care Gel, Discus Dental, LLC PDF, 68KB, File does not meet accessibility standards Date: 03. November 2014 Topics: Medical devices Type: Customer information

Product group Dental products - dental material
Reference 07174/14

Safety Notice for the therascreen BRAF RGQ PCR Kit, QIAGEN PDF, 85KB, File does not meet accessibility standards Date: 03. November 2014 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 06379/14

Corrective action for the Oxoid Listeria Latex Kit, Thermo Fisher Scientific PDF, 39KB, File does not meet accessibility standards Date: 03. November 2014 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 05628/14

Corrective action for the product LeoniPlus, Heinen + Löwenstein GmbH & Co. KG PDF, 329KB, File does not meet accessibility standards Date: 30. October 2014 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 06943/14

Recall for Medex Intracranial Drainage Sets, Smiths Medical Deutschland GmbH PDF, 272KB, File does not meet accessibility standards Date: 30. October 2014 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 07149/14

Recall for the products megro ID plus und megroCID, Megro GmbH & Co. KG PDF, 2MB, File does not meet accessibility standards Date: 30. October 2014 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - cleaning / disinfection / sterilisation
Reference 07161/14

Safety Information for the Rocket® IPC Drainage Bottle, Rocket Medical PDF, 91KB, File does not meet accessibility standards Date: 30. October 2014 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - drainages and suction systems
Reference 07022/14

Corrective action for the Vapotherm Precision Flow Disposable Patient Circuit, Vapotherm, Inc. PDF, 45KB, File does not meet accessibility standards Date: 30. October 2014 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 05460/14

Corrective action for the Galt VTI® Valved Tearaway Introducer, Galt Medical Corp. PDF, 53KB, File does not meet accessibility standards Date: 30. October 2014 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 07030/14

Urgent Safety Notice for the diagnostic ultrasound systems ARIETTA 60 & 70 series, Hitachi Aloka Medical Ltd. PDF, 90KB, File does not meet accessibility standards Date: 29. October 2014 Topics: Medical devices Type: Customer information

Product group Ultrasonics - ultrasonic diagnostic equipment
Reference 06699/14

Corrective action for the OEC 9800, FlexiView 8800, OEC MiniView 6800 and OEC UroView 2800 systems, GE Healthcare PDF, 80KB, File does not meet accessibility standards Date: 29. October 2014 Topics: Medical devices Type: Customer information

Product group Radiological technology - mobile radiological diagnostic facilities
Reference 07120/14

Urgent Safety Notice for the DAR™ Breathing System, Mapleson B and C configurations, Covidien LLC PDF, 24KB, File does not meet accessibility standards Date: 29. October 2014 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 07100/14

Recall for the MembraneBlue® Dual Ophthalmic Surgical Liquid, distributed in Germany, D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. PDF, 78KB, File does not meet accessibility standards Date: 29. October 2014 Topics: Medical devices Type: Customer information

Product group ophthalmological technology - liquid media for ophthalmological purposes
Reference 04397/14

Corrective action for the products Discovery MR750, Optima MR450w and Discovery MR750w, GE Healthcare PDF, 66KB, File does not meet accessibility standards Date: 29. October 2014 Topics: Medical devices Type: Customer information

Product group Electromedical fields - equipment for MR tomography
Reference 07090/14

Corrective action for the CMF Mandible External Fixator System I and II, Synthes GmbH PDF, 3MB, File does not meet accessibility standards Date: 29. October 2014 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 07004/14

Urgent Safety Notice for the Monitor– Defibrillator DEFIGARD 5000, SCHILLER MEDICAL SAS PDF, 48KB, File does not meet accessibility standards Date: 28. October 2014 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 06720/14

Recall for the AMS 700 Accessory Kit - Lightning Bolt Keith Needles, American Medical Systems PDF, 139KB, File does not meet accessibility standards Date: 28. October 2014 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 07031/14

Corrective action for the Philips IntelliVue Patient Monitors and Philips Avalon Fetal Monitors, Philips Healthcare PDF, 107KB, File does not meet accessibility standards Date: 28. October 2014 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 07046/14