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Recall for the Insufflation hose, silicone, XION GmbH PDF, 306KB, File does not meet accessibility standards Date: 17. August 2015 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - endoscopes
Reference 05355/15

Recall for the VEPTR® Caudal Rib Supports (Rib-to-Rib Construct only), Synthes GmbH PDF, 4MB, File does not meet accessibility standards Date: 17. August 2015 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 04930/15

Recall for the product Hyperventilation mask, Yuyao Shengchang Medical Instrument Factory PDF, 8KB, File does not meet accessibility standards Date: 17. August 2015 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 02676/15

Corrective action for the Sapphire Infusion Pump, Q Core Medical PDF, 120KB, File does not meet accessibility standards Date: 17. August 2015 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 05004/15

Corrective action for the Pioneer® Plus Catheter, Volcano Corporation PDF, 87KB, File does not meet accessibility standards Date: 13. August 2015 Topics: Medical devices Type: Customer information

Product group Ultrasonics - ultrasonic diagnostic equipment
Reference 04858/15

Corrective action for the Access Thyroglobulin Reagent Kit, Beckman Coulter PDF, 31KB, File does not meet accessibility standards Date: 13. August 2015 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 04955/15

Urgent Safety Notice for the TraumaDiagnost systems, Philips Medical Systems PDF, 20KB, File does not meet accessibility standards Date: 13. August 2015 Topics: Medical devices Type: Customer information

Product group Radiological technology - stationary radiological equipment
Reference 05101/15

Recall for AngioJet® Thrombectomy Sets, Boston Scientific International S.A. PDF, 161KB, File does not meet accessibility standards Date: 13. August 2015 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 05074/15

Corrective action for the TRIGEN 8/7 mm x 24 cm Humeral Nail, Smith & Nephew Inc. PDF, 79KB, File does not meet accessibility standards Date: 13. August 2015 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 05086/15

Recall for the product HQD Flow Probe, Transonic Systems, Inc. PDF, 1MB, File does not meet accessibility standards Date: 13. August 2015 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 04702/15

Updated Safety Information concerning NDI Disposable Reflective Marker Sphere, Northern Digital Inc. PDF, 372KB, File does not meet accessibility standards Date: 13. August 2015 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - cardiac/thorax surgery
Reference 04089/15

Corrective action for the ExacTrac 6.0 Patient Positioning System, Brainlab AG PDF, 327KB, File does not meet accessibility standards Date: 11. August 2015 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiotherapy treatment planning systems
Reference 04957/15

Recall for the E-tegra Stent Graft System, JOTEC GmbH PDF, 537KB, File does not meet accessibility standards Date: 11. August 2015 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 04689/15

Recall for the ARROW® International PICC Kits with Peel-Away Sheath Component, Arrow International, Inc. PDF, 188KB, File does not meet accessibility standards Date: 11. August 2015 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 04858/15

Corrective action for the Philips G60 patient monitor, Philips Goldway (Shenzhen) Industrial Inc. PDF, 167KB, File does not meet accessibility standards Date: 11. August 2015 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 05168/15

Recall for the Mucolexx / Mucolytic Agent, Richard Allan Scientific PDF, 534KB, File does not meet accessibility standards Date: 11. August 2015 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 03437/15

Corrective action concerning the M6 service head, Ondal Medical Systems GmbH PDF, 5MB, File does not meet accessibility standards Date: 10. August 2015 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 04659/15

Corrective action for the rollator TOPRO Troja 2G, TOPRO Industri AS PDF, 770KB, File does not meet accessibility standards Date: 10. August 2015 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology - daily living aids
Reference 03527/15

Recall for the EOPA® Arterial Cannula, Medtronic PDF, 95KB, File does not meet accessibility standards Date: 10. August 2015 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - syringes and cannulas
Reference 04903/15

Corrective action for the RHK femoral components, Biomet UK Ltd. PDF, 2MB, File does not meet accessibility standards Date: 10. August 2015 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 04167/15

Corrective action for the ST AIA-PACK 25-OH Vitamin D CALIBRATOR SET, Tosoh Corporation PDF, 221KB, File does not meet accessibility standards Date: 10. August 2015 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 04711/15

Corrective action for the iChemVELOCITY systems using iChemVELOCITY Urine Chemistry Strips, Beckman Coulter, Inc. PDF, 1MB, File does not meet accessibility standards Date: 04. August 2015 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 04459/15

Recall of MANI Trocar Kit, MANI, Inc. PDF, 22KB, File does not meet accessibility standards Date: 04. August 2015 Topics: Medical devices Type: Customer information

Product group ophthalmological technology - equipment for ophthalmological therapeutics
Reference 04328/15

Recall for the product Oxoid MacConkey Agar No. 3, Thermo Fisher Scientific PDF, 279KB, File does not meet accessibility standards Date: 04. August 2015 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 04355/15

Urgent Safety Notice for the product BD BBL™ CHROMagar™ MRSA II, Becton Dickinson PDF, 58KB, File does not meet accessibility standards Date: 04. August 2015 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 04586/15

Corrective action for the Fluitest CREA PAP and for all products based on the “Trinder Reaction”, Analyticon Biotechnologies AG PDF, 40KB, File does not meet accessibility standards Date: 04. August 2015 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 04443/15

Corrective action for the adjustable positioning elements, MAQUET GmbH PDF, 884KB, File does not meet accessibility standards Date: 04. August 2015 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 03020/15

Urgent Safety Notice for the BD CD56 PE-Cy™7 reagent, Becton, Dickinson & Company, BD Biosciences PDF, 50KB, File does not meet accessibility standards Date: 03. August 2015 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 04451/15

Urgent Safety Notice for the Samsung LABGEOPT Lipid Test 5S and LABGEOPT Lipid Test 5, Samsung Electronics PDF, 153KB, File does not meet accessibility standards Date: 03. August 2015 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 04231/15

Urgent Safety Notice for the DFM Transcatheter Aortic Valve System, Direct Flow Medical® PDF, 223KB, File does not meet accessibility standards Date: 03. August 2015 Topics: Medical devices Type: Customer information

Product group Non-active implants - cardiac surgery
Reference 04668/15