Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 both a guiding sheath and introducer sheath. The Halo One Thin-Walled Guiding Sheath is indicated for use in peripheral arterial and venous procedures requ

U.S. FDA — Device Enforcement · United States · 2016-12-02 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0969-2017
Date of alert: 2016-12-02
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: BARD PERIPHERAL VASCULAR, INC
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 50137570

Reported risk: Complaints of sheath separation, kinking, and/or tip damage during use.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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