Z-2360-2019 Class II Terminated
FDA device recall Z-2360-2019 was initiated by Leventon S. A. U. on May 23, 2019 and is designated Class II. Reason for recall: The product lacks 510(k) clearance, and therefore is misbranded and must be removed from the U.S. market. The recall status is terminated (terminated June 8, 2020). Affected quantity: 1700.
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