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

Recall Z-0949-2017 — PreludeEASE Hydrophilic Sheath Introducer Dilator The Merit PreludeEASE Hydrophilic Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries, including but not limited to the radial artery, while maintaining hemostasi

U.S. FDA — Device Enforcement · United States · 2016-12-01 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0949-2017
Date of alert: 2016-12-01
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Merit Medical Systems, Inc.
Product category: device
Product type: Devices

Reported risk: Recalling dilators included with the 6F PreludeEASE Hydrophilic Sheath Introducer because the dilator tips were manufactured with an undersized inner diameter and therefore will not allow passage of an 0.021 (0.53 mm) guide wire.

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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