FDA Slaps a Class I Recall on C.R. Bard's Halo One Thin-Walled Guiding Sheaths
The FDA today announced a Class 1 recall of C.R. Bard’s (NYSE:BCR) the Halo One thin-walled guiding sheaths over issues associated with sheath separation, kinking and tip damage during use.
The Murray Hill, N.J.-based company’s Halo One sheath is designed to introduce and guide the placement of interventional or diagnostic devices into veins and arteries through an incision on the patient’s leg.
A Class 1 indication from the federal watchdog indicates “a reasonable probability that use of these products will cause serious adverse health consequences or death,” according to the agency.
The Murray Hill, N.J.-based company’s Halo One sheath is designed to introduce and guide the placement of interventional or diagnostic devices into veins and arteries through an incision on the patient’s leg.
A Class 1 indication from the federal watchdog indicates “a reasonable probability that use of these products will cause serious adverse health consequences or death,” according to the agency.