Search Results for: catheter

A Brief History of Polypropylene Mesh

May 16, 2017 By US Recall News 1 Comment

Polypropylene is the second most popular plastic, making up 27% of all manufactured plastics. Phillips Petroleum claims it developed the polypropylene commercial process in 1951 when it was trying to figure out what to do with its natural gas reserves. Polypropylene is cheap. It is made from the byproducts of the refining process in the … [Read more...]

Vascular Solutions, Inc. Issues Recall of Guardian® II Hemostasis Valves

April 11, 2016 By The FDA Leave a Comment

Vascular Solutions, Inc. (Nasdaq: VASC), initiated a nationwide recall of Guardian II hemostasis valves used in catheterization procedures. Specific lots of the products have been recalled because they pose an increased risk of air leakage that may lead to an air embolism, which could result in serious injury or death. … [Read more...]

Bracco Diagnostics Inc. Issues Voluntary Nationwide Recall of Isovue® (iopamidol injection) Pre-Filled Power InjectorSyringes due to Presence of Particulates

December 1, 2012 By The FDA Leave a Comment

Bracco Diagnostics Inc. (BDI) is voluntarily initiating a Class I recall of nine (9) lots of Isovue® (iopamidol injection) Pre-Filled Power Injector Syringes (Isovue PFS, to be used in combination with Stellant® CT Injection Systems) due to the presence of visible particles in syringes observed at the end of standard stability studies on retained … [Read more...]

Cardiovascular Systems ViperSheath Sheath Introducer – Recall

December 5, 2009 By The FDA Leave a Comment

Recall Class: Class I Date Recall Initiated: October 21, 2009 Product: ViperSheath Sheath Introducer is manufactured by Thomas Medical Products, Inc. and is distributed by Cardiovascular Systems, Inc. (CSI). Lot Ranges Catalog Numbers S28117 through S29174 VPR-ISH 5 X 85, VPR-ISH 6 X 85, VPR-ISH 7 X 85, VPR-ISH 5 X 45, VPR-ISH 6 X 45, VPR-ISH 7 … [Read more...]

Cardiovascular Systems Recalls ViperSheath Sheath Introducer

November 18, 2009 By The FDA Leave a Comment

Cardiovascular Systems, Inc. has announced a voluntary recall of all lots of the ViperSheathTMSheath Introducer on behalf of Thomas Medical due to reports about stretching or fracture of the sheath during use. CSI initiated the nationwide recall on November 2, 2009. The ViperSheathTM Sheath Introducer is a product developed and manufactured by … [Read more...]