Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.02.2017 – 28.02.2017

Опубліковано 13.03.2017 о 00:00


Німеччина

http://www.bfarm.de/SiteGlobals/Forms/Suche/EN/kundeninfo_Filtersuche_Formular_en.html?nn=4527724

 

Lot recall of LaserEdge Knives, Valeant Pharmaceuticals International Inc. / Bausch & Lomb

ophthalmological technology – equipment for ophthalmological therapeutics

PDF511KB

Recall of Lotus valve system, Boston Scientific International S.A.

Non-active implants – cardiac surgery

PDF430KB

Recall of ball electrode, inomed Medizintechnik GmbH

Medical electronics / Electromedical devices – electrotherapy

PDF132KB

Lot recall of Check-Flo hemostasis assembly / Flexor radial access sets / TriForce peripheral crossing set / Check-Flo introducer (Hausdorf-lock atrial), Cook Medical Europe

Injections / Infusions / Transfusions / Dialysis – catheters

PDF77KB

Batch recall of custom procedure packs containing Medtronic / Covidien Devon Light Gloves, Pennine

Surgical equipment/ Anaesthesia – surgical equipment

PDF319KB

Urgent field safety notice for evo and eco c, Schwarzer Cardiotek GmbH

Medical electronics / Electromedical devices – electrodiagnostics

PDF266KB

Urgent field safety notice for LIFEPAK 15 monitor / defibrillator, PHYSIO-CONTROL Inc.

Medical electronics / Electromedical devices – electrotherapy

PDF36KB

Urgent field safety notice for modular femoral heads (CoCr) / Protasul S30 femoral heads / Metasul heads, Zimmer Biomet / Zimmer GmbH

Non-active implants – bone surgery

PDF158KB

Recall of syringe 100 ml with catheter tip and Luer adapter, Fuhrmann GmbH

Injections / Infusions / Transfusions / Dialysis – syringes and cannulas

PDF57KB

Recall of Stoma support ring KR-XX, Koring AG

Orthopaedic / Rehabilitation technology – care of natural and artificial body orifices

PDF125KB

Urgent field safety notice for ProteusPLUS and ProteusONE, IBA

Radiotherapy / Radiation protection – nuclear medical therapeutic equipment

PDF258KB

Lot recall of Bone Wax Stick, B. Braun Surgical S.A.

Dressings / Pads – ointments and gels

PDF119KB

Urgent field safety notice for Helical infusion catheter and steerable Morph universal guide catheter, BioCardia Inc.

Injections / Infusions / Transfusions / Dialysis – catheters

PDF133KB

Lot recall of STADA diagnostic H.pylori self-tests, MEXACARE GmbH

In-vitro diagnostics – immunological products

PDF119KB

Urgent field safety notice for Unyvero BCU blood culture (Propionibacterium acnes), Curetis GmbH

In-vitro diagnostics – instruments, apparatuses and systems

PDF366KB

Urgent field safety notice for RFX/SFX / Legacy / Precision 500D, GE Healthcare

Radiological technology – stationary radiological equipment

PDF604KB

Recall of radial head prosthesis MoPyC, Tornier

Non-active implants – bone surgery

PDF345KB

Urgent field safety notice for Aiming Arm for DFN / combined / for PAD, DePuy Synthes / Synthes GmbH

Medical instruments for use in humans – bone surgery

PDF347KB

Urgent field safety notice for Offset Cup Impactor Universal, Brainlab AG

Surgical equipment/ Anaesthesia – surgical equipment

PDF140KB

Recall of FlexTherm Heater Cooler Device, Sorin / LivaNova

Surgical equipment/ Anaesthesia – surgical equipment

PDF64KB

Lot recall of Monosyn undyed 7/0 (0,5) 45 cm DSMP7, B. Braun Surgical S.A.

Dressings / Pads – surgical sutures, vascular loops etc.

PDF231KB

Urgent field safety notice for Oncentra External Beam Oncentra Brachy, Elekta AB / Nucletron B.V.

Radiotherapy / Radiation protection – radiotherapy treatment planning systems

PDF153KB

Lot recall of TIPSS-200 Transjugular Intrahepatic Portosystemic Shunt Procedure Pack, William Cook Europe Aps / Cook Medical Europe

Non-active implants – special implants

PDF46KB

Lot recall of NuPortCT and C-PortCT port catheter systems containing F9.6 silicone catheters, PHS Medical GmbH

Non-active implants – special implants

PDF411KB

Lot recall of MobiCath Bi-Directional Guiding Sheath, Greatbatch Medical / MPS Medical Product Service GmbH

Injections / Infusions / Transfusions / Dialysis – catheters

PDF137KB

Lot recall of various spine instruments, DePuy Synthes / Synthes GmbH

Medical instruments for use in humans – bone surgery

PDF291KB

Lot recall of Devon™ Light Gloves, Medtronic GmbH

Surgical equipment/ Anaesthesia – surgical equipment

PDF61KB

Recall of ProcedurePak trays containing Syringe 100 ml 3parts Cath. tip Conc. W/LS Adapter (BD Plastipak Syringe, Catheter tip with Luer slip adaptor), Mölnlycke Health Care

Injections / Infusions / Transfusions / Dialysis – syringes and cannulas

PDF167KB

Lot recall of Safil Violet 2/0 (3) 12×45 cm, B. Braun Surgical S.A.

Dressings / Pads – surgical sutures, vascular loops etc.

PDF264KB

Lot recall of Menicon soft 72, Menicon Co. Ltd.

ophthalmological technology – contact lenses

PDF164KB

Lot recall of sterile disposable feeding bottles / sterile disposable breast milk collector sets, Beldico S.A.

General equipment for medical treatment – medico-mechanical devices

PDF98KB

Lot recall of 1.5 mm Hydro Valvulotome, LeMaitre Vascular GmbH

Medical instruments for use in humans – cardiac/thorax surgery

PDF654KB

Urgent field safety notice for dilator and sheath length 460 mm / d 1,7 mm (F5) / with haemostatic valve, Ecomedis Medizintechnik GmbH

Medical instruments for use in humans – gynaecology

PDF54KB

Urgent field safety notice for ExacTrac Vero 3.5.0 – 3.5.3, Brainlab AG

Radiotherapy / Radiation protection – radiotherapy treatment planning systems

PDF273KB

Urgent field safety notice for ceiling unit CU 5001/3 and CU 3-21/23, MÖLLER-WEDEL GmbH & Co. KG

Optics / Precision engineering – medical microscopes (does not incude laboratory microscopes)

PDF254KB

Urgent field safety notice for VERSAJET II Hydrosurgery System Console, Smith & Nephew Medical Ltd.

Surgical equipment/ Anaesthesia – surgical equipment

PDF93KB

Urgent field safety notice for MetaToe ReadyToUse Kit, Merete GmbH

Non-active implants – bone surgery

PDF249KB

Urgent field safety notice for iChemVELOCITY automated urine chemistry systems, Beckman Coulter / Iris International

In-vitro diagnostics – equipment / products for clinical chemistry

PDF42KB

Urgent field safety notice for Kleihauer Kit, IMMUCOR Medizinische Diagnostik GmbH

In-vitro diagnostics – haematological, histological and cytological products

PDF76KB

Urgent field safety notice for Elecsys TSH / PTH, Roche Diagnostics

In-vitro diagnostics – immunological products

PDF102KB

Lot recall of Super Arrow-Flex Percutaneous Sheath Introducer Set, Arrow International Inc. / Teleflex Medical

Injections / Infusions / Transfusions / Dialysis – catheters

PDF183KB

Urgent field safety notice for MEDUCORE Easy battery packs, WEINMANN Emergency Medical Technology GmbH + Co. KG

Medical electronics / Electromedical devices – electrotherapy

PDF41KB

Recall of Plastipak Syringe, Catheter tip with Luer slip adapter 100 ml, Becton Dickinson (BD) / Lohmann & Rauscher GmbH & Co. KG

Injections / Infusions / Transfusions / Dialysis – syringes and cannulas

PDF29KB

Urgent field safety notice for XRCISE STRESS ECHO MED, ERGO-FIT GmbH & Co. KG / cardiowise GmbH

Medical electronics / Electromedical devices – functional diagnostics by way of gas exchange and exercise

PDF236KB

Lot recall of Valleylab Laparoscopic Handset Four-Function, Medtronic

Medical electronics / Electromedical devices – electrotherapy

PDF153KB

Urgent field safety notice for ULTRASOUND VIDEO BRONCHOSCOPE EB-1970UK, PENTAX Europe GmbH

Optics / Precision engineering – endoscopes

PDF62KB

Lot recall of clip applicator, MTW-Endoskopie W. Haag KG

Medical instruments for use in humans – general instruments

PDF40KB

Lot recall of Accu-Cut Saw Blade AO Drive, Zimmer Biomet UK Ltd.

Surgical equipment/ Anaesthesia – surgical equipment

PDF502KB

Recall of HeartMate PHP Catheter, Abbott

Active implantable medical devices – artificial hearts

PDF78KB

Batch recall of Intraocular lenses CT ASPHINA 409MP, Carl Zeiss Meditec AG

Non-active implants – special implants

PDF82KB

Batch recall of LEGION HINGE KNEE FEMORAL ASSEMBLY, Smith & Nephew Inc.

Non-active implants – bone surgery

PDF110KB

Recall of Li-Ion Battery used with Maquet CARDIOSAVE Hybrid IABP / Rescue IABP, Maquet Getinge Group

Surgical equipment/ Anaesthesia – surgical equipment

PDF117KB

Recall of StarClose SE Vascular Closure System, Abbott Vascular Deutschland GmbH

Non-active implants – special implants

PDF227KB

Urgent field safety notice for Kiwi Omni Cup, Clinical Innovations

Medical instruments for use in humans – gynaecology

PDF148KB

Urgent field safety notice for Atrium Thoracic Catheters, Maquet Getinge Group

Injections / Infusions / Transfusions / Dialysis – drainages and suction systems

PDF46KB

Urgent field safety notice for Artis systems with software versions VC14 / VC21 / VD10 / VD11 und VE10, Siemens Healthcare GmbH

Radiological technology – radiological equipment for vascular diagnostics

Urgent field safety notice for Artis zee systems with specific delivery losts of the A100Plus generator in combination with 2-focus Megalix Cat Plus tube units, Siemens Healthcare GmbH

Radiological technology – radiological equipment for vascular diagnostics

PDF674KB

Urgent field safety notice for digital linear accelerators of type PRIMUS / MEVATRON, Siemens Healthcare GmbH

Radiotherapy / Radiation protection – radiation facilites with accelerators for teletherapy

PDF20KB

Urgent field safety notice for digital linear accelerators of type ARTISTE / ONCOR / PRIMUS, Siemens Healthcare GmbH

Radiotherapy / Radiation protection – radiation facilites with accelerators for teletherapy

PDF23KB

Urgent field safety notice for Strata II / Strata NSC Valves (including Burr Hole and Lumbar Peritoneal [LP]), Medtronic

Non-active implants – special implants

PDF58KB

Urgent field safety notice for trailer kit 24598 and 24875 in trikes without rear suspension Trix / Kettwiesel / Trets Reh, Hase Bikes

Orthopaedic / Rehabilitation technology – mobility aids

PDF11KB

Urgent field safety notice for ETEST XM256 (Cefuroxime), bioMérieux SA

In-vitro diagnostics – microbiological products

PDF161KB

Lot recall of Xpert BCR-ABL, Cepheid

In-vitro diagnostics – immunological products

PDF410KB

Recall of C2 CryoBalloon Controller Cap, C2 Therapeutics Inc.

Surgical equipment/ Anaesthesia – surgical equipment

PDF250KB

Urgent field safety notice for Discovery MR450 narrow bore 1.5T MRI, GE Healthcare

Electromedical fields – equipment for MR tomography

PDF301KB

Urgent field safety notice for RayStation 2.5 / 3.0 / 3.5 / 4.0 / 4.5 / 4.7 / 5.0 / 4.3 (InverseArc), RaySearch Laboratories AB

Radiotherapy / Radiation protection – radiotherapy treatment planning systems

PDF629KB

Urgent field safety notice for 3M™ Tegaderm PICC CVC Securement Device + CHG I.V. Securement Dressing, 3M Deutschland GmbH

Dressings / Pads – dressings

PDF111KB

Lot recall of LASEREDGE 2.0 mm x 2.0 mm Trapezoid Angled 6/Box, Valeant Pharmaceuticals International Inc.

ophthalmological technology – equipment for ophthalmological therapeutics

PDF372KB

Urgent field safety notice for RayStation 4.5 / 4.7 / 5 / 6, RaySearch Laboratories AB

Radiotherapy / Radiation protection – radiotherapy treatment planning systems

PDF405KB

Lot recall of LEGION CRUCIATE RETAINING NARROW Femoral Component SZ 5 RT, Smith & Nephew Inc.

Non-active implants – bone surgery

PDF63KB

Lot recall of FOCUS FORCE intraocular lenses, Anadolu Tip Teknolojileri A.S.

Non-active implants – special implants

PDF160KB

 

Якщо ви знайшли помилку, будь ласка, виділіть фрагмент тексту та натисніть Ctrl+Enter.

Print button Версія для друку