🔍 RecallPedia

SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for single use.

Class I - Dangerous
🏥 Medical Devices Recalled: February 22, 2021 Sirtex Medical Limited Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot Numbers: 1031234, 1031225, 1031227, 1031229
  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:
Sirtex Medical Limited
Reason for Recall:
There is a potential presence of particulate matter in the D-Vial.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for single use.

Product Codes/Lot Numbers:

Lot Numbers: 1031234, 1031225, 1031227, 1031229

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1275-2021

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