🔍 RecallPedia

DOSI-FUSER 12591 5-500D1 -USA, 12591 5-600D1 -USA Provide parenteral drug infusions at a constant flow without impeding patient mobility

Class I - Dangerous
🏥 Medical Devices Recalled: May 23, 2019 Leventon S. A. U. Infusion Pumps

What Should You Do?

  1. Check if you have this product:
    172055L, 1721 10L, 1 807881, 181 1401 Unique Device Identifier (UDI) 08436020767470, 08436020768026
  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:
Leventon S. A. U.
Reason for Recall:
The product lacks 510(k) clearance, and therefore is misbranded and must be removed from the U.S. market.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

DOSI-FUSER 12591 5-500D1 -USA, 12591 5-600D1 -USA Provide parenteral drug infusions at a constant flow without impeding patient mobility

Product Codes/Lot Numbers:

172055L, 1721 10L, 1 807881, 181 1401 Unique Device Identifier (UDI) 08436020767470, 08436020768026

Distribution:

Distributed in: US, AZ, CA, MA, MI, PR, FL

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2360-2019