FDA-Device2019-09-04Class II
DOSI-FUSER 12591 5-500D1 -USA, 12591 5-600D1 -USA Provide parenteral drug infusions at a constant flow without impeding patient mobility
Leventon S. A. U.
Hazard
The product lacks 510(k) clearance, and therefore is misbranded and must be removed from the U.S. market.
Sold states
US Distribution to states in: AZ, CA, MA, MI, PR, and FL.
Affected count
1700
Manufactured in
Calle Newton 18 24, Sant Esteve Sesrovires, Barcelona, N/A, Spain
Products
DOSI-FUSER 12591 5-500D1 -USA, 12591 5-600D1 -USA Provide parenteral drug infusions at a constant flow without impeding patient mobility
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2360-2019Don't want to check this manually?
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