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.

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.