Recall Z-0968-2017— BARD PERIPHERAL VASCULAR, INC
Class I · Terminated
Class I FDA medical device recall by BARD PERIPHERAL VASCULAR, INC, initiated 2016-12-02, terminated 2017-04-05. It names one FDA 510(k) clearance: K161183. 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. Reason: Complaints of sheath separation, kinking, and/or tip damage during use..
- Recalling firm
- BARD PERIPHERAL VASCULAR, INC
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2016-12-02
- Terminated
- 2017-04-05
- Firm location
- Tempe, AZ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.