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
Reported: January 25, 2017 Initiated: December 2, 2016 #Z-0968-2017
Product Description
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
Reason for Recall
Complaints of sheath separation, kinking, and/or tip damage during use.
Details
- Recalling Firm
- BARD PERIPHERAL VASCULAR, INC
- Units Affected
- 101 units
- Distribution
- Nationwide Distribution to NY, MO, NY, NY, FL, KS, MI, TX, NV, OH, ME, WA, LA, AZ, UT, NH. No foreign distribution.
- Location
- Tempe, AZ
Frequently Asked Questions
What product 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. Recalled by BARD PERIPHERAL VASCULAR, INC. Units affected: 101 units.
Why was this product recalled? ▼
Complaints of sheath separation, kinking, and/or tip damage during use.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 25, 2017. Severity: Critical. Recall number: Z-0968-2017.
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