🔍 RecallPedia

Destination Guiding Sheath catheter introducer, Catalog Number: RSR06 Product Usage: The Destination¿ Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal, carotid, and peripheral arteries.

Class I - Dangerous
🏥 Medical Devices Recalled: September 12, 2017 Terumo Medical Diagnostic Equipment

What Should You Do?

  1. Check if you have this product:
    Lot: VK09, Expiration Date: 31-Jan-2020
  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:
Terumo Medical Corporation
Reason for Recall:
The tucking depth feature of this catheter introducer is marginally outside the upper specification.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Destination Guiding Sheath catheter introducer, Catalog Number: RSR06 Product Usage: The Destination¿ Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal, carotid, and peripheral arteries.

Product Codes/Lot Numbers:

Lot: VK09, Expiration Date: 31-Jan-2020

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0725-2018

Related Recalls