Leventon S. A. U.: Medical Device Recall in 2019 - (Recall #: Z-2360-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: May 23, 2019

Date Posted: September 4, 2019

Recall Number: Z-2360-2019

Event ID: 83017

Reason for Recall:

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

Status: Terminated

Product Quantity: 1700

Code Information:

172055L, 1721 10L, 1 807881, 181 1401 Unique Device Identifier (UDI) 08436020767470, 08436020768026

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated