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Urgent Field Safety Notice for Copan eSwab by Copan Italia S.p.A. PDF, 461KB, File does not meet accessibility standards Date: 19. October 2021 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - auxiliary equipment
Reference 22284/21

Urgent Field Safety Notice for IVA by BALT Extrusion PDF, 1MB, File does not meet accessibility standards Date: 19. October 2021 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 22930/21

Urgent Field Safety Notice for CombiSet® TAVI, Hybrid Mediclin, Schrittmacherset by PAUL HARTMANN AG PDF, 663KB, File does not meet accessibility standards Date: 19. October 2021 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 22304/21

Urgent Field Safety Notice for Philips Azurion system by Philips Medical Systems Nederland B.V. PDF, 2MB, File does not meet accessibility standards Date: 18. October 2021 Topics: Medical devices Type: Customer information

Product group Radiological technology - radiological equipment for vascular diagnostics
Reference 22884/21

Urgent Field Safety Notice for EcoGel by Eco-Med Pharmaceuticals Inc. PDF, 2MB, File does not meet accessibility standards Date: 18. October 2021 Topics: Medical devices Type: Customer information

Product group Ultrasonics - ultrasonic diagnostic equipment
Reference 22868/21

Urgent Field Safety Notice for Cardiosave Hybrid/Rescue IABP by Maquet (vorher: Datascope Corp) PDF, 247KB, File does not meet accessibility standards Date: 18. October 2021 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 20019/21

Urgent Field Safety Notice for ProteusPLUS by IBA (Ion Beam Applications) PDF, 232KB, File does not meet accessibility standards Date: 18. October 2021 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - nuclear medical therapeutic equipment
Reference 10395/21

Urgent Field Safety Notice for Transseptal Needle by Cook Inc. PDF, 233KB, File does not meet accessibility standards Date: 15. October 2021 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 22437/21

Urgent Field Safety Notice for Accudrain / Hermetic / LimiTorr / MoniTorr by Integra Life Sciences Corporation PDF, 218KB, File does not meet accessibility standards Date: 15. October 2021 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 22424/21

Urgent Field Safety Notice for Cordis S.M.A.R.T. Flex Vascular Stent System by Cordis Cashel PDF, 242KB, File does not meet accessibility standards Date: 15. October 2021 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 22429/21

Urgent Field Safety Notice for 3M Red Dot Universal EKG-Elektrode by 3M Health Care PDF, 496KB, File does not meet accessibility standards Date: 15. October 2021 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 21695/21

Urgent Field Safety Notice for TiLite by Permobil GmbH PDF, 204KB, File does not meet accessibility standards Date: 15. October 2021 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology - mobility aids
Reference 21693/21

Urgent Field Safety Notice for PRIMEDIC Heart Save (PAD, AED, AS, AED-M) by Metrax GmbH PDF, 259KB, File does not meet accessibility standards Date: 15. October 2021 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 19321/21

Urgent Field Safety Notice for PrisMax Hemodialysis Machine by Baxter PDF, 177KB, File does not meet accessibility standards Date: 15. October 2021 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - dialysis technology
Reference 22275/21

Urgent Field Safety Notice for Paratherm, Heater/Cooler by Chalice Medical Ltd. PDF, 110KB, File does not meet accessibility standards Date: 15. October 2021 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 18269/21

Urgent Field Safety Notice for Mepilex Border Lite by Mölnlycke Health Care AB PDF, 4MB, File does not meet accessibility standards Date: 15. October 2021 Topics: Medical devices Type: Customer information

Product group Dressings / Pads - dressings
Reference 22003/21

Urgent Field Safety Notice for various medical devices by Cook Incorporated PDF, 329KB, File does not meet accessibility standards Date: 14. October 2021 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - other products for injections / infusions / transfusions / dialysis
Reference 22278/21

Urgent Field Safety Notice for Tibbs Arterial Cannula, Micro Olive by DTR Medical Ltd PDF, 145KB, File does not meet accessibility standards Date: 14. October 2021 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - syringes and cannulas
Reference 22175/21

Urgent Field Safety Notice for TETANUS VIRCLIA IgG MONOTEST by Vircell S.L. PDF, 2MB, File does not meet accessibility standards Date: 14. October 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 21295/21

Urgent Field Safety Notice for VIDAS Immuno-Assays products by bioMérieux S. (Marcy- l'Etoile) PDF, 1MB, File does not meet accessibility standards Date: 14. October 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 21648/21

Urgent Field Safety Notice for Sealsafe, Tissuesafe Plus by Milestone S.R.L. PDF, 36KB, File does not meet accessibility standards Date: 14. October 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - others
Reference 19209/21

Urgent Field Safety Notice for Aptio Automation by Inpeco SA PDF, 806KB, File does not meet accessibility standards Date: 14. October 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 20428/21

Urgent Field Safety Notice for HE Synthetic Standard SARS-CoV-2 Process Control by Microbiologics, Inc. PDF, 225KB, File does not meet accessibility standards Date: 14. October 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 19926/21

Urgent Field Safety Notice for HE Synthetic Standard SARS-CoV-2 Process Control by Microbiologics, Inc. PDF, 224KB, File does not meet accessibility standards Date: 14. October 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 20040/21

Urgent Field Safety Notice for API 50 CH by bioMérieux S. (Marcy- l'Etoile) PDF, 635KB, File does not meet accessibility standards Date: 12. October 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 22052/21

Urgent Field Safety Notice for Flexor Introducer Sheath by Cook Inc PDF, 181KB, File does not meet accessibility standards Date: 12. October 2021 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 22046/21

Urgent Field Safety Notice for Atellica IM 1300 and IM 1600 Analyzers by Siemens Healthcare Diagnostics Inc. Tarrytown PDF, 259KB, File does not meet accessibility standards Date: 12. October 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 21836/21

Urgent Field Safety Notice for Anti-SARS-CoV-2-QuantiVac ELISA (IgG) by EUROIMMUN Medizinische Labordiagnostika AG PDF, 231KB, File does not meet accessibility standards Date: 12. October 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 21786/21

Urgent Field Safety Notice for Stem-Kit Reagents 50 Tests by Immunotech PDF, 129KB, File does not meet accessibility standards Date: 12. October 2021 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 21988/21