FDA-Device2017-01-25Class I
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.
BARD PERIPHERAL VASCULAR, INC
Hazard
Complaints of sheath separation, kinking, and/or tip damage during use.
Sold states
Nationwide Distribution to NY, MO, NY, NY, FL, KS, MI, TX, NV, OH, ME, WA, LA, AZ, UT, NH. No foreign distribution.
Affected count
101
Manufactured in
1415 W 3rd St, Tempe, AZ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0970-2017Don't want to check this manually?
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