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Manufacturers
Johnson & Johnson Medical Pty Ltd
제조사 모회사 (2017)
Johnson & Johnson
Source
DHTGA
50 Events
HARMONIC ACE + Shears with Adaptive Tissue Technology 의 리콜
5mm ENDOPATH XCEL Trocars with Optiview Technology 의 리콜
Thermocool Smarttouch SF Bi-Directional Navigation Catheter 의 리콜
MobiCath Bi-Directional Guiding Sheath, Small Curve(used to introduce cardiovascular catheters) 의 리콜
Ethicon Mersilene Tape (intended for use in circular suture of the cervix) 의 리콜
Sterrad 100NX system (Sterilisation system) 의 리콜
Ethicon Physiomesh Flexible Composite Mesh 의 리콜
Cordis PRECISE PRO RX Nitinol Stent System (Carotid) 의 리콜
Biosense Webster PENTARAY NAV and PENTARAY NAV eco Catheters (used for electrophysiological mapping of the heart) 의 리콜
Omrix Pressure Regulators (used to spray Evicel Solutions for Fibrin Sealent during open and laproscopic procedures to prevent bleeding) 의 리콜
Gynecare Thermachoice III Thermal Balloon Ablation Silicone Catheter 의 리콜
Ethicon HARMONIC ACE+ 7 Laparoscopic Shears 의 리콜
GYNEMESH PS and TVT DevicesGynemesh PS 의 리콜
EVOTECH Endoscope Cleaner and Reprocessor (ECR) 의 리콜
CIDEX OPA Solution Test Strips 의 리콜
ThermoCool SmartTouch Catheter Family (used to facilitate electrophysiological mapping of the heart and to undertake RF ablations) 의 리콜
Omrix Pressure Regulator (Surgical air pipeline regulator) 의 리콜
Cordis EMPIRA NC RX PTCA Dilatation Catheter (“75RxxyyyN”) and Cordis EMPIRA RX PTCA Dilatation Catheter (“85RxxyyyS”)(indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion) 의 리콜
MENTOR Gel Sizers (Sizer for mammary prosthesis) 의 리콜
ThermoCool SF NAV Catheter Family 의 리콜
PentaRay Nav Catheter (used for multiple electrode electrophysiological mapping of cardiac structures in the heart) 의 리콜
STERRAD 100S Cassettes 의 리콜
Proceed Surgical MeshProduct Code PCDT1 의 리콜
DePuy CMW 2 Gentamicin Bone Cement 20 g 의 리콜
STERRAD 100S, STERRAD 50 and STERRAD NX Sterilisation Systems 의 리콜
EVOTECH Endoscope Cleaner and Reprocessor (ECR) 의 리콜
STERRAD 100NX (Gas Plasma Steriliser) 의 리콜
STERRAD Boosters and Adaptors (used in STERRAD NX steriliser and contains hydrogen peroxide sterilant) 의 리콜
OPTEASE Retrievable Vena Cava Filter 의 리콜
Straight Adjustable Gastric Band Product Code: 2200X & BD2XV 의 리콜
Thermocool SmartTouch Bi-Directional Navigation Catheter and Thermocool SmartTouch Uni-Directional Navigation Catheter (used to facilitate electrophysiological mapping of the heart and to undertake RF ablations) 의 리콜
Inspira Air Balloon Dilation System (Bronchial balloon catheter) 의 리콜
STERRAD 100NX Cassette (Used to provide hydrogen peroxide sterilant used in the STERRAD NX Steriliser) 의 리콜
ECHELON 60mm Endoscopic Linear Cutter Reloads, Black (Reload cartridge with two 60mm long triple-staggered lines of staples) 의 리콜
LIGACLIP 10mm M/L Endoscopic Rotating Multiple Clip Applier (metal ligating clip applier) 의 리콜
Electrosurgery Probe Plus II (Electrosurgical electrodes) & Laparoscopic Banding Kit 의 리콜
EnSeal G2 SuperJaw (Used for bipolar coagulation and mechanical transection of tissue during laparoscopic and open procedures) 의 리콜
EVOTECH Endoscope Cleaner and Reprocessor (ECR) System (Endoscope disinfecting unit) 의 리콜
EVOTECH Endoscope Cleaner and Reprocessor (ECR) System (Endoscope disinfecting unit) 의 리콜
STERRAD 100NX and STERRAD 200 Sterilisation Systems 의 리콜
One Touch Verio IQ Blood Glucose Monitoring System 의 리콜
Confidence Spinal Cement System 11cc Plus Kit, Confidence Spinal Cement System KitAll lot numbers affected 의 리콜
ENSEAL G2 Curved and Straight Tissue Sealer Devices (used in endoscopic procedures) 의 리콜
MOBICATH Bi-Directional Guiding Sheath, small curve (used to introduce cardiovascular catheters)Small Curve 의 리콜
STERRAD CYCLESURE 24 Biological Indicators (sterilisation process indicator) 의 리콜
Cordis ExoSeal Vascular Closure Device (femoral artery compression device) 의 리콜
PSX Proximate Skin Staple Extractor (staple remover) 의 리콜
Proximate PPH Hemorrhoidal Circular Stapler and Accessories 33mm, Product code PPH03 and Proximate HCS Hemorrhoidal Circular Stapler and Accessories 33mm, Product code PPH01 (Used for treatment of prolapse and hemorrhoids) 의 리콜
STERRAD 100S System Cassettes (To provide the hydrogen peroxide sterilant used in the STERRAD Steriliser) 의 리콜
STERRAD CYCLESURE 24 Biological Indicators within Validation Kits - (sterilisation process indicator) Biological Indicators within Validation Kits:STERRAD NX Validation Kit – STERRAD 100NX Validation Kit – STERRAD 100S/50 Validation Kit 의 리콜
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데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 50 건
HARMONIC ACE + Shears with Adaptive Tissue Technology
모델명 / 제조번호(시리얼번호)
HARMONIC ACE + Shears with Adaptive Tissue TechnologyProduct Code: HAR23 and HAR231Lot Numbers: P9125C, P94C8R, P94G1W, P9125C, P9125C, P94C8R, P94G1W, P9125CARTG Number: 118011(Johnson & Johnson Medical - Electrode, electrosurgical, active, ultrasonic/mechanical vibration, single-use)
의료기기 분류등급
General and Plastic Surgery Devices
5mm ENDOPATH XCEL Trocars with Optiview Technology
모델명 / 제조번호(시리얼번호)
5mm ENDOPATH XCEL Trocars with Optiview TechnologyBladeless 5x100 StabilityProduct Code 2B5LTBatch Numbers: P4T58Y, P4T665, P4T83K, P4T88G, P4T927, R4000W, R4004GBladeless 5X75 StabilityProduct Code 2B5STBatch Numbers: P4T745, P4T906, P4T91HSleeve 5x100 StabilityProduct Code 2CB5LTBatch Numbers: P4T636, P4T63G, P4T708, P4T89NSleeve 5x75 StabilityProduct Code 2CB5STBatch Numbers: P4T686, P4T99K,P4T79AExpiry: between Sep 2022 - Jan 2023ARTG: 108472, 108482
Thermocool Smarttouch SF Bi-Directional Navigation Catheter
모델명 / 제조번호(시리얼번호)
Thermocool Smarttouch SF Bi-Directional Navigation CatheterProduct Number: D134805Lot Numbers.: 17682911L and 17685902LARTG Number: 233355
MobiCath Bi-Directional Guiding Sheath, Small Curve(used to introduce cardiovascular catheters)
모델명 / 제조번호(시리얼번호)
MobiCath Bi-Directional Guiding Sheath, Small Curve(used to introduce cardiovascular catheters)Product Number: D140010Lot Number: W3338707ARTG Number: 191013
Ethicon Mersilene Tape (intended for use in circular suture of the cervix)
모델명 / 제조번호(시리얼번호)
Ethicon Mersilene Tape (intended for use in circular suture of the cervix)Product Codes: RS21, RS22, D9212All unexpired lotsARTG Number: 165076
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여기
Johnson & Johnson Medical Pty Ltd T/A Depuy Australia
제조사 모회사 (2017)
Johnson & Johnson
Source
DHTGA
Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes
제조사 모회사 (2017)
Johnson & Johnson
Source
DHTGA
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