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 perform…

Recall date

December 2, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0968-2017

FDA classification

Class I

Brand / firm

BARD PERIPHERAL VASCULAR, INC

Sold / distributed

Nationwide Distribution to NY, MO, NY, NY, FL, KS, MI, TX, NV, OH, ME, WA, LA, AZ, UT, NH. No foreign distribution.

Why it was recalled

Complaints of sheath separation, kinking, and/or tip damage during use.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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