🔍 RecallPedia

THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA

Class I - Dangerous
🏥 Medical Devices Recalled: December 10, 2021 Mallinckrodt Pharmaceuticals Ireland Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Dunnage case consists of a random unknown lot, which may have been shipped in place of Kit lot K341
  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:
Mallinckrodt Pharmaceuticals Ireland Ltd
Reason for Recall:
This recall was initiated to recover a Dunnage Case, which is a case of three (3) CLXUSA kits. This Dunnage Case was shipped on 02-Dec-2021. Dunnage is used during the sterilization process and is not intended for customer use.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA

Product Codes/Lot Numbers:

Dunnage case consists of a random unknown lot, which may have been shipped in place of Kit lot K341

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0567-2022