Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

A sheath used to deliver therapeutic or diagnostic intravascular devices or fluids through the skin is being recalled by the distributor as a result of complaints about stretching or fracture of the sheath during use which have lead to patient injury, according to an announcement by the Food and Drug Administration (FDA).

The nationwide recall includes all lots of the CROSSOVER Sheath Introducer, a product developed and manufactured by Thomas Medical Products, Inc., and distributed by Cordis. It is a long-coil reinforced, kink-resistant catheter sheath intended for use in arterial and venous procedures requiring the percutaneous, or through the skin, introduction of therapeutic or diagnostic intravascular devices or fluids.

Read the rest of this entry »