Leventon S. A. U. product recalled over labeling errors
- Recall date
- May 23, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Leventon S. A. U. recalls DOSI-FUSER 12591 5-500D1 -USA, 12591 5-600D1 -USA Provide parenteral drug infusions at a constant flow without impeding…
- Recall number
- Z-2360-2019
- FDA classification
- Class II
- Brand / firm
- Leventon S. A. U.
- Sold / distributed
- US Distribution to states in: AZ, CA, MA, MI, PR, and FL.
Why it was recalled
The product lacks 510(k) clearance, and therefore is misbranded and must be removed from the U.S. market.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
DOSI-FUSER 12591 5-500D1 -USA, 12591 5-600D1 -USA Provide parenteral drug infusions at a constant flow without impeding patient mobility
Get recall alerts
Free email alert whenever Leventon S. A. U. has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Leventon S. A. U.