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BARD PERIPHERAL VASCULAR, INC recalls Halo One 5F Introducer Sheath 10 cm 5 pack Product Code: HAL510F Product Usage: The Halo One Thin-Walled Guiding Sh
Recalled January 25, 2017 · FDA recall Z-0970-2017 · BARD PERIPHERAL VASCULAR
Hazard
Complaints of sheath separation, kinking, and/or tip damage during use. · FDA Class I
Units
101
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 10 cm 5 pack Product Code: HAL510F Product Usage: The Halo One Thin-Walled Guiding Sheath is designed to perform as both a guiding sheath and introducer sheath. The Halo One Thin-Walled Guiding Sheath is indicated for use in peripheral arterial and venous procedures requiring percutaneous introduction of intravascular devices. The Halo One Thin-Walled Guiding Sheath is NOT indicated for use in the neurovasculature nor the coronary vasculature.
Manufacturer(s)
BARD PERIPHERAL VASCULAR, INC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →