Recall Z-2360-2019— Leventon S. A. U.

Name: FDA recall Z-2360-2019
Creator: U.S. Food and Drug Administration
Published: 2019-05-23

Class II · Terminated

Class II FDA medical device recall by Leventon S. A. U., initiated 2019-05-23, terminated 2020-06-08. FDA's recall record names no specific 510(k) clearance for this event. Product: DOSI-FUSER 12591 5-500D1 -USA, 12591 5-600D1 -USA Provide parenteral drug infusions at a constant flow without impeding patient mobility. Reason: The product lacks 510(k) clearance, and therefore is misbranded and must be removed from the U.S. market..

Recalling firm: Leventon S. A. U.
Classification: Class II
Status: Terminated
Initiated: 2019-05-23
Terminated: 2020-06-08
Firm location: Barcelona, N/A, Spain

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.