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Medical Devices Recalls

* NB: You can click on الجهاز المعني بالمتابعة to preview the official letter.
الجهاز المعني بالمتابعة الماركة الوكيل تاريخ + رقم الصادر الموجه اليه
Pulsar-18 and Pular-35 peripheral self-expanding nitinol stent systems Boston Scientific   3/6/2015  
HeartAttendant Interface Cables GE Healthcare   3/6/2015  
BiPAP autoSV Advanced System One Medtronic Limited   3/6/2015  
RPO where Micra® Transcatheter Pacing System software version 1.1 Philips   3/6/2015  
Specific Neuromuscular Transmission Modules, E-NMT-00 and M-NMT-02, ReliantHeart Inc GMM 3/6/2015  
RELIANCE 4-FRONTTM single coil defibrillation leads Biotronic   3/6/2015  
TigerPaw System II Laax, Inc.   19/05/2015  
Baxter Healthcare. Pump Infusion Pca Baxter Healthcare Corp.   19/05/2015  
Bivona® Inner Cannula Smiths Medical PRIMEmedical 19/05/2015  
Bard® Max-Core® Disposable Core Biopsy Instrument Bard   19/05/2015  
Accu-Chek® Spirit Combo insulin pump Roche Diagnostics   19/05/2015  
PPH Basic Insertion Pack Teleflex Medical Sterimed LTD./ Novamed S.A.R.L. 19/05/2015  
Stryker CBC II Wound Drains and Ambulating Bulb Stryker Ets.F.A Kettaneh 19/05/2015  
SynchroMed® II Implantable Drug Infusion Pump Medtronic INTERMEDIC S.A.L./ PRIMEmedical/ Tamer Frères S.A.L. 11/05/2015  
Revaclear 400, Lot 4-9502-H-01 Gambro   11/05/2015  
Cellnovo Insulin Infusion System Cellnovo   11/05/2015  
AVEA ® ventilator all models CareFusion   11/05/2015  
CSA Medical truFreeze Spray Kit CSA Medical   11/05/2015  
Harris Oxygen Flowmeter HGEA Pty Ltd   11/05/2015  
Ebola Virus One-Step Test Kits Lusys Laboratories, Inc   29/04/2015  
Ameda Manual Breast Pump Ameda, Inc.   07/04/2015  
Reclaim Revision Hip System; Assembles Implant Inserter Adaptor DePuy Orthopaedics, Inc. Asmar Medical 07/04/2015  
FemFlex II Pediatric Femoral Arterial Cannula Edwards Lifesciences, LLC Benta Trading 07/04/2015  
CODMAN® 3000 Refill Kit – Huber Needles DePuySynthes Asmar Medical 07/04/2015  
Integra Flowable Wound Matrix Integra Lifesciences Asmar Medical 07/04/2015  
ADAC VERTEX Plus, CARDIO, SOLUS or VERTEX V60 imaging system Philips Healthcare Intermedic 07/04/2015  
Sleeve for ASLS, 5.0mm, resorbable DePuySynthes Asmar Medical 07/04/2015  
Philips Juno DRF Philips Healthcare Intermedic 07/04/2015  
GIF-XP190N Endoscope Olympus Intermedic 07/04/2015  
FIAB Disposable electrodes for Defibrillation series F7965 FIAB SpA   07/04/2015  
Oxford Tibial Tray Biomet Biomedic S.A.R.L. 07/04/2015  
Olympus Duodenoscope model TJF-Q180V     02/04/2015  
Catalys Precision Laser System Hospital   02/04/2015  
Baxter Healthcare HomeChoice Pro APD System Baxter Healthcare Corp.   02/04/2015  
Persona Trabecular Metal Tibial Plate/ Persona TM Tibia Zimmer, Inc. INTERMEDIC S.A.L. 02/04/2015  
BIRMINGHAM HIP™ Modular Head Smith & Nephew   02/04/2015  
LAAx, Inc. TIGERPAW® System II LAAx, Inc.   02/04/2015  
DePuy - LCS COMPLETE RPS Knee System DePuy Synthes Asmar Medical 02/04/2015  
Expel™ Drainage Catheter with Twist-Loc™ Hub Boston Scientific Medilife s.a.l. 02/04/2015  
Accu-Chek® Insight insulin pump cartridge Roche   09/03/2015  
Trauma DHS/DCS Impactor Tip DePuy Synthes Asmar Medical 09/03/2015  
Baxter peritoneal dialysis Transfer sets, Titanium adapters, Connection Shield, Minicaps and Opticaps Baxter   09/03/2015  
Hospira Plum A+ and Plum A+3 Infusion Systems Hospira Inc   09/03/2015  
Zimmer Zimmer, Inc INTERMEDIC S.A.L. 09/03/2015  
Apollo Therapy Laser Pivotal Health Solutions   09/03/2015  
Maquet Cardiosave Maquet Datascope Corp- Cardiac Assist Division   09/03/2015  
Allura Xper R7.2. x (Fluoroscopic diagnostic x-ray system) Plilips Healthcare Intermedic 03/03/2015  
T2100 and T2000 Treadmill power cords GE Healthcare GME 03/03/2015  
Teleflex Medical, Maquet Servo Humidifier 163 Teleflex Medical   03/03/2015  
HeartWare Ventricular Assist System (VAS) Heart Ware   03/03/2015  
Cholangiopancreatography (ERCP) Duodenoscopes     03/03/2015  
Hudson RCI Tracheal Tubes Teleflex Medical   03/03/2015  
Wright
Medical’s SHANNON BURR XL 2.0MM X 20MM
Wright Medical UK Allied Medical Group S.A.L. 03/03/2015  
FlowSens injector Medex   03/03/2015  
Allura FC PHILIPS
Healthcare
Intermedic 03/03/2015  
Edwards Commander Delivery System Models 9610TF23, 9610TF26, 9610TF29 Edwards Lifesciences LLC Benta Trading 03/03/2015  
Alcon® Small Volume Syringes 200μL Luer-Lok Alcon   03/03/2015  
Hydrophilie Acrylic Single Use lntraocular Lens system packs Rayner Sterimed LTD. 17/2/2015  
GORE® TIGRIS® Vascular Stent W. L. GORE & ASSOCIATES, INC. Allied Medical Group S.A.L. 17/2/2015  
TM Ardis® Interbody System Solid, Part #06-702-02071, Lot #62430812 Zimmer Intermedic S.A.L. 17/2/2015  
Crystalens® AO (PMA P030002) Intra Ocular Lens Bausch & Lomb Intermedic S.A.L. 17/2/2015  
Persona Tibial Articular Surface Inserter (Instrument) Zimmer Intermedic S.A.L. 17/2/2015  
Various Sterile-Packaged Femoral Heads and Tapers Zimmer Intermedic S.A.L. 17/2/2015  
Ivory Reamer 10mm and 11mm – several lots Stryker Ets.F.A Kettaneh 17/2/2015  
Philips Model MPT7-4 Transesophageal Transducer Philips Healthcare Inetrmedic 17/2/2015  
MRU Connection; all GE Healthcare MRI systems with superconducting magnets GE Healthcare GMM 17/2/2015  
IntellaTip MiFi™ Open-Irrigated Ablation Catheter Boston Scientific Medilife s.a.l./ Dima Health Care 17/2/2015  
Bi-Manual Irrigating / Aspirating Handpieces Aspen Medical   17/2/2015  
Monnal T50 ventilators Air Liquide   17/2/2015  
Covidien Trellis 6 Peripheral Infusion System/ Covidien Trellis 8 Peripheral Infusion System Covidien Allied Medical Group S.A.L./ Dima Health Care/ Mediline 17/2/2015  
Fresenius Crit Line Fresenius Medical Care Holdings, Inc.   17/2/2015  
AK 200 S and AK 200 ULTRA S nocturnal home hemodialysis machines Gambro Ltd   17/2/2015  
M2a 38 Acetabular Cup, M2a 38 Femoral Head, M2a Magnum Tri-Spike Acetabular Cup & M2a Magnum Femoral Heads Biomet Inc Biomedic SARL 17/2/2015  
Animas Vibe Insulin Infusion Pump Animas Corporation   28/1/2015  
Philips Model MPT7-4 Transesophageal Transducer Philips Healthcare Intermedic 28/1/2015  
Bone Graft Substitutes     28/1/2015  
Philips IntelliVue TcG10 Philips Medical Systems, Inc. Intermedic 28/1/2015  
RTH8 Rotor Iris Diagnostics   28/1/2015  
PLATINUM, BACCARA Platinum, PLATINUM dRF, BACCARA Platinum dRF and
AGIL FPD
Apelem Med Consul 20/1/2015  
MEDPOR Surgical Implant/ MEDPOR BARRIER Sheets Stryker Ets.F.A Kettaneh 20/1/2015  
Various Sterile-Packaged Femoral Heads and Tapers Zimmer INTERMEDIC S.A.L. 20/1/2015  
Philip’s Anesthesia Machines Negative Pressure Limiter (NPL) valve Philips INTERMEDIC S.A.L. 20/1/2015  
Luer Slip IV Syringe IVS60 Medicina   20/1/2015  
Luer Lock IV Syringe IVL60 Medicina   20/1/2015  
Manually Retractable Safety Syringe MRXX & MR05L Medicina   20/1/2015  
Keyhole Dressing KDXX Medicina   20/1/2015  
Rectal Straw RC075 7.5cm & RC150 15cm Medicina   20/1/2015  
HeartWare® Controller HeartWare   20/1/2015  
Proteus XR/a and Revolution XR/d systems. GE Healthcare GMM 20/1/2015  
FiberOptix Intra-Aortic Balloon Arrow International, Inc. Novamed S.A.R.L. 20/1/2015  
Prescription eyeglass safety lenses Eyemart Express Ltd   13/1/2015  
Ascension Orthopedics PyroSphere CMC & PyroSphere TMT Integra LifeSciences Corp. Asmar Medical 13/1/2015  
Sensei X Robotic Catheter System St Jude Medical Inc Basic Trading Company 13/1/2015  
Cheek Retractor, f/MatrixMANDIBLE U-shaped, flexible Synthes Inc   13/1/2015  
Maquet QuadroxID Pediatric Diffusion Membrane Oxygenator Maquet Cardiovascular Us Sales   13/1/2015  
LENTIS HydroSmart foldable Intraocular lenses (IOL) Oculentis GmbH   13/1/2015  
Autopen Classic, Autopen 24, Densupen and Autopen 3ml for Teriparatide Owen Mumford   13/1/2015  
Trilogy Bone Screws Zimmer Pty Ltd INTERMEDIC S.A.L. 5/1/2015  
Defibrillation Electrode for Children GE Healthcare General Medical Equipement 5/1/2015  
TC-PLUS™ Tibial Resection Guide proximal; VKS Tibia Guide proximal EU Smith&Nephew   5/1/2015  
DePuy Synthes Trauma RIA
(Reamer/Irrigator/Aspirator) system
DePuy Synthes   5/1/2015  
Sterrad 50, Sterrad 100S, Sterrad 200, Sterrad 100NX and Sterrad NX System Cassettes ASP   5/1/2015  
MIT-H Offset Cup Impactor Link   5/1/2015  
IntellaMap Orion Boston Scientific Medilife s.a.l. 5/1/2015  
CT Transcatheter Aortic Valve Philips INTERMEDIC S.A.L. 5/1/2015  
Updated Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy     2/1/2015  
Titanium Mandible Implants Biomet Microfixation Biomedic S.A.R.L. 2/1/2015  
Healon EndoCoat Opthalmic Viscosurgical Device Abbott Medical Optics Inc.   2/1/2015  
Lotus Valve System Boston Scientific Medilife s.a.l. 2/1/2015  
10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170MM Sterile Synthes, Inc   2/1/2015  
Stellaris PC with Laser System (Cataract extraction/vitrectomy system) Baush & Lomb Inc INTERMEDIC S.A.L. 2/1/2015  
Gelflex Sterile Eye Wash Normal Saline 10ml Ampoule Covidien Dima Healthcare/ Mediline 2/1/2015  
Navigator Surgical Kit/ Tapered Navigator Certain Surgical Kit/ Contra-Angle Torque Driver Kit/ Contra-Angle Torque Driver Kit for Certain Internal Connection/ Contra-Angle Torque Driver Kit for Certain and External Connection/ Contra-Angle Torque Driver Kit/ Prosthetic Instrumentation System Biomet 3i Inc. Biomedic S.A.R.L. 2/1/2015  
DePuy ReClaim Reamer Extension DePuySynthes   2/1/2015  
GW01 Gastrostomy Guide Wire Medicina   2/1/2015
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