🔍 RecallPedia

Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D-1385-01-S, RX CE 2797, Sterile

Class I - Dangerous
🏥 Medical Devices Recalled: February 21, 2023 Biosense Webster Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot # 00002137; UDI (GTIN) : 10846835016253
  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:
Biosense Webster, Inc.
Reason for Recall:
Incorrect labeling; specifically, the product name, lot number and product code on the carton label for Bi-Directional Guiding Sheaths does not match the inner label pouch
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D-1385-01-S, RX CE 2797, Sterile

Product Codes/Lot Numbers:

Lot # 00002137; UDI (GTIN) : 10846835016253

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1319-2023

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