FDA Device recall Z-2360-2019
DOSI-FUSER 12591 5-500D1 -USA, 12591 5-600D1 -USA Provide parenteral drug infusions at a constant flow without impeding patient mobility
- FDA Device
- Class II
- terminated
- Published 2019-09-04
On 2019-09-04 the FDA classified a Class II recall of DOSI-FUSER 12591 5-500D1 -USA, 12591 5-600D1 -USA Provide parenteral drug infusions at a constant flow without impeding patient mobility by Leventon S A U, citing the product lacks 510(k) clearance, and therefore is misbranded and must be removed from the U.S. market.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2360-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-05-23 |
| Published | 2019-09-04 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Leventon S A U |
| Distribution | AZ, CA, FL, MA, MI, PR |
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.
Identifiers
| code_info | 172055L, 1721 10L, 1 807881, 181 1401 Unique Device Identifier (UDI) 08436020767470, 08436020768026 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2360-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.