Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
DOSI-FUSER 12591 5-500D1 -USA Recalled by Leventon S. A. U. Due to The product lacks 510(k) clearance, and therefore is...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Leventon S. A. U. directly.
Affected Products
DOSI-FUSER 12591 5-500D1 -USA, 12591 5-600D1 -USA Provide parenteral drug infusions at a constant flow without impeding patient mobility
Quantity: 1700
Why Was This Recalled?
The product lacks 510(k) clearance, and therefore is misbranded and must be removed from the U.S. market.
Where Was This Sold?
This product was distributed to 5 states: AZ, CA, FL, MA, MI
About Leventon S. A. U.
Leventon S. A. U. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report