FDA Device recall Z-0970-2017
Halo One 5F Introducer Sheath 10 cm 5 pack Product Code: HAL510F Product Usage: The Halo One Thin-Walled Guiding Sheath is designed to perf…
- FDA Device
- Class I
- terminated
- Published 2017-01-25
On 2017-01-25 the FDA classified a Class I recall of Halo One 5F Introducer Sheath 10 cm 5 pack Product Code: HAL510F Product Usage: The Halo One Thin-Walled Guiding Sheath is designed to perf… by Bard Peripheral Vascular, citing complaints of sheath separation, kinking, and/or tip damage during use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0970-2017 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2016-12-02 |
| Published | 2017-01-25 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Bard Peripheral Vascular |
| Distribution | US |
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.
Reason
Complaints of sheath separation, kinking, and/or tip damage during use.
Identifiers
| code_info | Product Code Lot Number UDI Number Quantity HAL510F 50137866 (01)00801741129698(17)170331(10)50137866 58 HAL510…Product Code Lot Number UDI Number Quantity HAL510F 50137866 (01)00801741129698(17)170331(10)50137866 58 HAL510F 50137924 (01)00801741129698(17)170331(10)50137924 73 HAL510F 50138170 (01)00801741129698(17)170331(10)50138170 89 HAL510F 50138765 (01)00801741129698(17)170531(10)50138765 27 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0970-2017%22
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