Search Results for: catheter

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...]

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, 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...]

Cordis Corporation announced today a nationwide voluntary recall of all lots of the CROSSOVER™ Sheath Introducer due to complaints about stretching or fracture of the sheath during use. The CROSSOVER Sheath Introducer is a product developed and manufactured by Thomas Medical Products, Inc., and distributed by Cordis. It is a long-coil reinforced, … [Read more...]