Home / Recalls / Leventon S. A. U. / Z-2360-2019

Z-2360-2019 Class II Terminated

Recalled by Leventon S. A. U. — Barcelona, N/A

Recall Details

Product Type
Devices
Report Date
September 4, 2019
Initiation Date
May 23, 2019
Termination Date
June 8, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1700

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.

Distribution Pattern

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

Code Information

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