Tag: Medical
A3311-17 CONTINUOUS EPIDURAL 17G TUOHY () C47916 [Smiths Medical ASD, Inc.]
Updated Date: Oct 10, 2012 EST DailyMed Drug Label Updates for the last seven days (since Oct 10, 2012 EST)
Standard for the Fabrication, Control and Distribution of Antimicrobial Agents for Use on Environmental Surfaces and Certain Medical Devices (GUI-0049)
This standard is considered a voluntary standard and applies to fabricators, packagers/labellers, distributors, testers and importers of any antimicrobial agents for use on environmental surfaces and medical devices that are not invasive devices and are intended to come into contact with intact skin only. Health Canada RSS – Compliance and Enforcement, Drugs and Health Products
A3544-18 CONTINUOUS EPIDURAL 18G HUSTEAD () Kit [Smiths Medical ASD, Inc.]
Updated Date: Aug 23, 2012 EST DailyMed Drug Label Updates for the last seven days (since Aug 23, 2012 EST)
St. Jude Medical Riata Implantable Cardioverter Defibrillator (ICD) Leads: Safety Communication – Premature Insulation Failure
ICD lead malfunction may cause abnormal sensing or pacing, or delivery of inappropriate or no shock therapy, which could result in serious adverse events, including death. MedWatch Safety Alert RSS Feed
4804-20 SPINAL 22G WHITACRE () C47916 [Smiths Medical ASD, Inc.]
Updated Date: Aug 7, 2012 EST DailyMed Drug Label Updates for the last seven days (since Aug 7, 2012 EST)
Guidance on Medical Device Compliance and Enforcement (GUI-0073)
This document outlines the strategy and provides guidance for the medical device industry on Health Canada’s compliance and enforcement activities. This version of the document included updated web links and the incorporation of changes to the establishment licensing provisions which recently occurred due to the cost recovery initiative. Health Canada RSS – Compliance and Enforcement, [...]
Smiths Medical Medfusion Model 4000 Syringe Infusion Pump: Class I Recall – System Errors May Cause Device Shutdown
Delay or interruption of infusion therapy could result in serious injury and/or death. MedWatch Safety Alert RSS Feed
Maquet Medical Systems USA FLOW-i Anesthesia System: Class 1 Recall – Device Field Correction
Use of this product may cause serious adverse health consequences, including death. MedWatch Safety Alert RSS Feed
Nidek Medical Products Mark 5 Nuvo, Nuvo 8, and Nuvo Lite Oxygen Concentrators: Class I Recall – Risk of Fire, Loss of Supplemental Oxygen
A capacitor failure may result in a fire hazard and loss of supplemental oxygen, which can lead to serious adverse health consequences, including death. MedWatch Safety Alert RSS Feed
