🔍 RecallPedia

COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units

Class I - Dangerous
🏥 Medical Devices Recalled: March 21, 2023 Merit Medical Systems Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Lot # H2122096S1; UDI-DI: (00)884450525197
  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:
Custom sheath Introducer contains incorrect needle size
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units

Product Codes/Lot Numbers:

Lot # H2122096S1; UDI-DI: (00)884450525197

Distribution:

Distributed in: US

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1578-2023

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