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BARD PERIPHERAL VASCULAR, INC recalls Halo One 5F Introducer Sheath 45 cm Product Code: HAL545 The Halo One Thin-Walled Guiding Sheath is designed to perfor
Recalled January 25, 2017 · FDA recall Z-0968-2017 · BARD PERIPHERAL VASCULAR
Hazard
Complaints of sheath separation, kinking, and/or tip damage during use. · FDA Class I
Units
101 units
Sold at
Nationwide Distribution to NY, MO, NY, NY, FL, KS, MI, TX, NV, OH, ME, WA, LA, AZ, UT, NH. No foreign distribution.
Description
Complaints of sheath separation, kinking, and/or tip damage during use.
Product
Halo One 5F Introducer Sheath 45 cm Product Code: HAL545 The Halo One Thin-Walled Guiding Sheath is designed to perform as both a guiding sheathand introducer sheath. The Halo One Thin-Walled Guiding Sheath is indicated for use inperipheral arterial and venous procedures requiring percutaneous introduction of intravascular devices. The Halo One Thin-Walled Guiding Sheath is NOT indicated for use in cerebrovascular nor the coronary vasculature
Manufacturer(s)
BARD PERIPHERAL VASCULAR, INC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →