🔍 RecallPedia

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 hemostasis for a variety of diagnostic and therapeutic procedures. The access needle with inner metal needle and outer plastic cannula is used to gain access to the vein or artery for placement of guide wires

Class I - Dangerous
🏥 Medical Devices Recalled: December 1, 2016 Merit Medical Systems Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    Lots: H1014678, H1039272, H1029150, H1039269, H1029151
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Merit Medical Systems, Inc.
Reason for Recall:
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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 hemostasis for a variety of diagnostic and therapeutic procedures. The access needle with inner metal needle and outer plastic cannula is used to gain access to the vein or artery for placement of guide wires

Product Codes/Lot Numbers:

Lots: H1014678, H1039272, H1029150, H1039269, H1029151

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0949-2017

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