FDA Device recall Z-0969-2017
Halo One 5F Introducer Sheath 90 cm Product Code: HAL590 Product Usage: The Halo One Thin-Walled Guiding Sheath is designed to perform as b…
- 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 90 cm Product Code: HAL590 Product Usage: The Halo One Thin-Walled Guiding Sheath is designed to perform as b… 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-0969-2017 |
| 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 90 cm Product Code: HAL590 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 HAL590 50137570 (01)00801741111525(17)170331(10)50137570 95 HAL590…Product Code Lot Number UDI Number Quantity HAL590 50137570 (01)00801741111525(17)170331(10)50137570 95 HAL590 50137770 (01)00801741111525(17)170331(10)50137770 79 HAL590 50137979 (01)00801741111525(17)170331(10)50137979 95 HAL590 50138696 (01)00801741111525(17)170430(10)50138696 23 |
|---|
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-0969-2017%22
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