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

Recall Z-2588-2014 — GALT VALVED TEARAWAY INTRODUCER SET GALT VTI RX ONLY UNITS 7 STERILE EO Product Usage: Used in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral vasculature.

U.S. FDA — Device Enforcement · United States · 2014-07-25 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2588-2014
Date of alert: 2014-07-25
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Galt Medical Corporation
Product category: device
Product type: Devices

Reported risk: The adhesive used in the product could dislodge when objects are inserted through the valve which could pose an embolic risk to the patient.

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

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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.

Recall Z-2588-2014 — GALT VALVED TEARAWAY INTRODUCER SET GALT VTI RX ONLY UNITS 7 STERILE EO Product Usage: Used in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral vasculature.

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