Update: IV Fluid Shortage
FDA is aware of the shortage situation for intravenous (IV) solutions, particularly 0.9% sodium chloride injection (i.e., saline)
Calcium gluconate 10 percent Injections by Rx Formulations: Recall – Microbial Contamination
FDA notified healthcare professionals to follow up with patients who received calcium gluconate 10% injections made by Rx Formulations, Mesa, Ariz., between Nov. 7 and Dec. 11, 2013.
Medical Device Safety Alert: Edwards Lifesciences Femoral Arterial and Venous Cannula
Edwards Lifesciences has identified an increase in the use of our Femoral Arterial and Venous Cannula in adult and pediatric populations in a manner that is not intended
Shortage: Sodium Chloride 0.9% Injection Bags
Shortage: Sodium Chloride 0.9% Injection Bags
Baxter Initiates Worldwide Voluntary Recall Of Select Lots Of 5 percent Dextrose Injection, USP And 0.9 percent Sodium Chloride Injection, USP Intravenous (IV) Solutions
Baxter International Inc. announced today it has initiated a voluntary recall to the hospital/user level of one lot of 5 percent Dextrose Injection, USP and four lots of 0.9 percent Sodium Chloride Injection, USP due to particulate matter found in the solutions. Injecting a product containing particulate matter may result in blockages of blood vessels, which can result in stroke, heart attack or damage to other organs such as the kidney or liver.
Hospira Issues a Voluntary Nationwide Recall of One Lot of Lidocaine HCl Injection, USP, 2%, 5 Ml in 5 Ml Vial, Due to Presence of Particulate Matter
Lidocaine HCl Injection 2%, 5 ml Vial by Hospira: Recall - Presence of Particulate Matter
Postmarket Surveillance of Medical Devices: Current Capabilities and Future Opportunities
Recalls of cardiac implantable electrical devices (CIEDs) currently impact hundreds of thousands of patients worldwide.
FDA Regulation of Cardiovascular Devices and Opportunities for Improvement
This article reviews FDA regulation of cardiovascular devices and offers suggestions for strengthening the process while focusing on examples relevant to cardiac electrophysiologists.
Medical Device Safety and Recalls: Rare Serious Erosion Events Associated with St. Jude Amplatzer Atrial Septal Occluder (ASO)
FDA is alerting health care providers and patients that in very rare instances, tissue surrounding the Amplatzer ASO can break down (erode) and result in life-threatening emergencies that require immediate surgery.
Survey of Methods Used to Detect Bacterial Contamination of Platelet Products in the United States in 2011
An Internet-based survey of AABB member institutions was conducted from May to June 2012, to document current practices used in 2011 for bacterial detection in different PLT products and to assess the impact of the new standard.
Blood Component Recalls and Market Withdrawals: Frequency, Reasons, and Management in the United States
The U.S. Food and Drug Administration has issued several recent guidances that address transfusion service actions for dealing with specific infectious disease problems. This present article updates our 2004 recommendations as to when to notify physicians about transfused nonconforming blood components.