Etch 2011/08/09 Siemens AG Lantis Model No. 2011/08/09 Philips Medical Systems DMC GMBH EasyDiagnost Eleva Model No. 426058 2011/08/09 SCC Soft Computer SoftPath GUI v. 4.3.0.10 11 12 Model No. 566698 2011/08/09 2011/08/09 Edwards Lifesciences LLC EndoPlege Coronary Sinus Catheter Model No. EP Teleflex Medical A Rusch Female
Radifocus Angiographic Catheter is angiographic catheter intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the vascular system. It is also used to lead a guidewire or a catheter into the target site.
Oct 19 2021 The Cordis Corporation recently issued a recall of its Super Torque MB Angiographic Catheter with Radiopaque Marker Bands products after receiving complaints of injuries. The marker bands can potentially move or dislodge during the procedure if the catheter is trapped between another device and the vessel wall. Written by Anjelica Cappellino J.D.
Cordis SUPER TORQUE MB Angiographic Catheter Catalog Numbers Modified Std Cat. Numbers 532598A 532598B 532598C SRD6875MB SRD7040MB safety and quality of the products that Cordis supplies. Respectfully yours Vice President Global Quality and Regulatory Affairs Cordis . Title Smart Control
Calibration Catheters SUPER TORQUE MB.. 79 CATHETER SHEATH INTRODUCERS Angiographic Needles .. 115 Table of contents Johnson Johnson Medical Products Cordis Division 200 Whitehall Drive L3R 0T5 Markham CA Ontario Tel 1 416 386 5463 Fax 1 905 946 3089
Sep 24 2021 Patients Harmed Because of Defective Catheters Made by Cordis Corporation May be Entitled to Substantial Damages. The FDA has announced a recall of Cordis SUPER TORQUE MB Angiographic Catheter with Radiopaque Marker Bands due to the potential for the marker bands to move or dislodge during procedures.
Sep 24 2021 The FDA labeled the recall on Cordis Super Torque MB angiographic catheter with radiopaque marker bands as Class I the most serious type due to the potential for the markers bands to
About Cordis Kit . Cor Cordis duo appoint KM to preserve independence. As of October 2015 Cordis is a part of Cardinal Health bringing together two important players in the healthcare industry and creating an unmatched offering in the cardiovascular space that will ensure greater access to quality products and services worldwide.
Home / Product / CORDIS / SUPER TORQUE Plus Angiographic Catheter SUPER TORQUE Plus Angiographic Catheter. Category CORDIS. specification Reviews 0 Discussions 0 Cordis catheters are available in a broad variety of French sizes and configurations. These catheters combine an atraumatic tip with either a braided or nonbraided body
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2011/11/28 Cordis SUPER TORQUE MB Angiographic Catheter. Johnson Johnson. Medical HK N.A. N.A. Johnson Johnson. Medical HK 2011/11/29 AngioDynamics Inc VenaCureEVLT NeverTouch Procedure Kits MHRA 2011/011/017/291/013 FSN N.A. N.A. 2011/11/29 Edwards Life Sciences Inc VolumeView Thermodilution Cable MHRA
Oct 19 2021 Cordis Recalls SUPER TORQUE MB Angiographic Catheter with Radiopaque Marker Bands Due to Potential for Marker Bands to Move or The FDA has identified this as a Class I recall the most serious type of recall. Use of
Jan 07 2021 Class I Recall Cordis Recalls Super Torque MB Angiographic Catheter with Radiopaque Marker Bands Due to Potential for Marker Bands to Move or Dislodge. September 21 2021. Re Issued Emergency Use AuthorizationLetsGetChecked Inc.Color Health Inc
Product Description Resources SUPERTORQUE MB is a calibration catheter. It has a braided polyurethane shaft and comes in a pigtail shape. Unbraided tip .038 guidewire compatibility Polycarbonate hub Pigtail with 6 side holes 10 or 20 gold alloy marker bands Braided polyurethane body Cordis Product Catalogue Learn more about these products.
Jul 23 2021 Do not use the Super Torque MB Angiographic Catheters in procedures where entrapment of the catheter between endovascular devices and the vessel wall may occur. Affected products SUPER TORQUE MB Marker Band Flush Catheter Lot or serial number All lots. Model or catalog number 532 598A 532 598B 532 598C Companies Manufacturer
The FDA released on update on Cordis’s May 19 recall of its Super Torque MB angiographic catheter with radiopaque marker bands deeming it a Class 1 recall because of the risk of serious injury or death. The agency noted that the device’s marker bands may move or dislodge during surgical procedures which can happen when the catheter is trapped between another device
UPDATES ON GUIDELINE FOR REGISTRATION OF DRUG MEDICAL DEVICE AND MEDICAL DEVICE DRUG COMBINATION PRODUCTS 4TH EDITION. Event ID Cordis Cordis SUPER TORQUE MB Angiographic CatheterCorrection related to labeling of a specific subset of angiographic catheters Affected
Cordis Recalls Angiograph Catheter Due to Patient Injuries . Mddionline DA 18 PA 50 MOZ Rank 92. The Cordis Super Torque MB Angiographic Catheter with Radiopaque Marker Bands is used to visualize and measure parts of the vascular system when used with radiopaque X ray detectable contrast media The problem is that the marker bands can move or dislodge
Oct 19 2021 Overwashed Hands With That Squeaky Clean Feel Here’s What to Do. February 8 2022. Balancing Compassion With Equanimity
Field Safety Corrective Actions FSCAs are actions taken by manufacturers to reduce a risk of death or serious deterioration in the state of health associated with the use of a medical device. The FSCAs may include e.g. withdrawal of medical devices hereinafter referred as the „MDs or supplementary information for use of MD.
Avoid excessive friction on the SUPER TORQUE MB Angiographic Catheter. Avoid simultaneous introduction of the SUPER TORQUE MB Angiographic Catheter and aortic graft devices through the same sheath. Cordis is in the process of supplementing the SUPER TORQUE MB Angiographic Cather labeling to address the above points. Why you are
Super Torque Flush Catheters Super Torque MB Flush Catheters Nonbraided 5 65 70 110 .038 Pigtail Medtronic Vascular SiteSeer Double wire braid 4 5 6 80 100 110 125 4 F=.042 Cordis Corporation Tempo Angiographic Catheter cerebral Braided 4 5 40 65 100 125.038 Yes Select offering
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Nov 21 2011 Cordis Corporation. 14201 Nw 60th Ave. Miami Lakes FL 33014 2802. For Additional Information Contact. Hal Baden. 786 313 2000. Manufacturer Reason. for Recall. Cordis Corporation is issuing a Correction for their SUPER TORQUE MB Angiographic Catheter after receiving a report of marker bands dislodged during a procedure.
Sep 23 2021 Reason for Recall Armstrong Medical Limited is recalling this product due to reports that some AMSORB PLUS PREFILLED G CAN 1.0L canisters have difficulties with gas flow that may cause a reduced