Regulatory/Legal
Sep 21, 2015
INRatio2 PT/INR Professional Test Strips In April 2014, Alere recalled its INRatio2 PT/INR Professional Test Strips because patients reported conflicting...
Sep 21, 2015
Tiger Paw System II A recall of Maquet Medical Systems' Tiger Paw System II was announced in March 2015 after it was found that "incomplete closure...
Sep 21, 2015
Maquet Intra-Aortic Balloon Pumps Some of the intra-aortic balloon pumps (IABP) made by Maquet Datascope Corporation were recalled in March 2014 because...
Sep 21, 2015
NaturaLyte Fresenius' NaturaLyte Liquid Bicarbonate Concentrate was recalled in April 2014 because of its potential to "develop higher than expected...
Sep 21, 2015
Flexi-Seal CONTROL In April 2014, a Class I recall of ConvaTec's Flexi-Seal CONTROL Fecal Management System Kit was announced. According to the FDA...
Sep 21, 2015
Covidien Defibrillation Electrodes A recall was initiated in September 2014 for Covidien defibrillation electrodes and electrodes made by Covidien and...
Sep 17, 2015
OriGen VV13F Reinforced Dual Lumen ECMO Catheters OriGen Biomedical announced a recall in March 2015 for one lot of the OriGen 51 VV13F Reinforced Dual...
Sep 17, 2015
HVAD HeartWare's HVAD Ventricular Assist Device has been the subject of a number of recent recalls, described in a June 2015 company release. The HVAD is...
Sep 17, 2015
Is Robert Califf, nominated to be FDA commissioner, too close to industry? Jim Dickinson By nominating cardiologist Robert M. Califf to be FDA’s next...
Sep 14, 2015
OxyTote A Class I recall of the OxyTOTE Portable Oxygen Unit from the Western/Scott Fetzer Company was initiated in January 2015 because the oxygen...