Halo One 5F Introducer Sheath 45 cm Product Code: HAL545 The Halo One… — Class I medical device recall Z-0968-2017
Terminated recall by BARD PERIPHERAL VASCULAR, INC, reported 2017-01-25, distributed nationwide. Complaints of sheath separation, kinking, and/or tip damage during use.
| Recall number | Z-0968-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BARD PERIPHERAL VASCULAR, INC, Tempe, AZ, United States |
| Recall initiated | 2016-12-02 |
| Classified | 2017-01-18 |
| Reported by FDA | 2017-01-25 |
| Terminated | 2017-04-05 |
| Distributed | Nationwide (US) |
| Quantity | 101 units |
| UPC / GTIN / UDI-DI | 00801741111549 |
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 for recall
Complaints of sheath separation, kinking, and/or tip damage during use.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0968-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.