FDA recall Z-2360-2019

Leventon S. A. U. · Class II · device

Product

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

Reason for recall

The product lacks 510(k) clearance, and therefore is misbranded and must be removed from the U.S. market.

Distribution

US Distribution to states in: AZ, CA, MA, MI, PR, and FL.

Key facts

Status
Terminated
Initiation date
2019-05-23
Report date
2019-09-04
Termination date
2020-06-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Barcelona, N/A, Spain

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2360-2019