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FDA

 •  October 23, 2017

AUDIENCE: Pharmacy, Risk Manager ISSUE: Octapharma USA Inc. is initiating a voluntary market withdrawal of octagam 10% [Immune Globulin Intravenous (human)] 10% Liquid Preparation] that is labeled with lot numbers K724B8541 & K725A8541. Although there have been no reports of serious injury at this time, Octapharma has determined, through...

FDA

 •  May 5, 2017

Release The U.S. Food and Drug Administration today approved Radicava (edaravone) to treat patients with amyotrophic lateral sclerosis (ALS), commonly referred to as Lou Gehrig’s disease. “After learning about the use of edaravone to treat ALS in Japan, we rapidly engaged with the drug developer about filing a marketing application in the United...

FDA

 •  February 11, 2016

On January 6, 2016, Cook Medical initiated a voluntary recall of 360 specific lots of Single Lumen Central Venous Catheters and Pressure Monitoring Sets and Trays due to catheter tip fracture and/or separation. Globally, 17,827 devices are subject to this recall. The recalled products are specific versions and lot numbers of the Single Lumen...

FDA

 •  August 27, 2015

AUDIENCE: Risk Manager, Biomedical Engineering, Nursing
ISSUE: An error in the Alaris Syringe Pump model number 8110 triggers a visual and audible alarm and causes the pump to stop supplying the infusion to the patient. Even when the user clears the error code 351.6740, the syringe pump does not respond to key presses until the product is detached ...

FDA

 •  July 31, 2015

Audience: Health care facilities using the Hospira Symbiq Infusion System
Device: Symbiq Infusion System, Version 3.13 and prior versions
The Hospira Symbiq Infusion System is a computerized pump designed for the continuous delivery of general infusion therapy for a broad patient population.
It is primarily used in hospitals, or other acute and ...