🔍 RecallPedia

Soltive SuperPulsed Laser System TFL FIBER CLEAVER, Model Number TFL-AFC

Class I - Dangerous
🏥 Medical Devices Recalled: December 4, 2023 Olympus Corporation of the Americas Infusion Pumps Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot Number: All units sold prior to 2023
  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:
Olympus Corporation of the Americas
Reason for Recall:
The strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Olympus does not have validated cleaning and sterilization instructions. Use of a non-sterile fiber stripper or cleaver on a sterile fiber poses a risk of contamination.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Soltive SuperPulsed Laser System TFL FIBER CLEAVER, Model Number TFL-AFC

Product Codes/Lot Numbers:

Lot Number: All units sold prior to 2023

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0717-2024

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