Z-2360-2019Class II

DOSI-FUSER 12591 5-500D1 -USA, 12591 5-600D1 -USA Provide parenteral drug infusions at a constant flow...

Name: Z-2360-2019 DOSI-FUSER 12591 5-500D1 -USA, 12591 5-600D1 -USA Provide parenteral drug infusions at a constant flow...
Creator: Leventon S. A. U.
Published: 2019-05-23
License: https://open.fda.gov/license/

Leventon S. A. U. / initiated 2019-05-23 / Terminated / root cause: labeling and UDI

FDA source

Leventon S. A. U. began a recall of DOSI-FUSER 12591 5-500D1 -USA, 12591 5-600D1 -USA Provide parenteral drug infusions at a constant flow without impeding patient mobility on 2019-05-23. FDA classified it as Class II and gives the reason as "The product lacks 510(k) clearance, and therefore is misbranded and must be removed from the U.S. market". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2360-2019
Classification: Class II
Status: Terminated
Initiated: 2019-05-23
Posted: 2019-08-23
Terminated: 2020-06-08
Recalling firm: Leventon S. A. U.
Product: DOSI-FUSER 12591 5-500D1 -USA, 12591 5-600D1 -USA Provide parenteral drug infusions at a constant flow without impeding patient mobility
Product code: MEB Pump, Infusion, Elastomeric
Reason for recall: The product lacks 510(k) clearance, and therefore is misbranded and must be removed from the U.S. market.
Root cause tag: labeling and UDI
FDA root cause: No Marketing Application
Action: The Firm, LEVENTON, S.A.U., notified customers of recall on June 4, 2019. Distributors were asked to inform customers of the recall. Customers were instructed to return all unused product to the distributor. Distributors were told to destroy all returned product and any remaining product in inventory. Distributors were also provided with recall response forms to complete and return to the recalling firm. If you have questions or concerns, please contact: Quality Director LEVENTON S.A.U. Phone: + 34 93 8176316, Fax: +34 93 8176301 email : [email protected]
Quantity in commerce: 1700
Distribution: US Distribution to states in: AZ, CA, MA, MI, PR, and FL.
Product codes and lots: 172055L, 1721 10L, 1 807881, 181 1401 Unique Device Identifier (UDI) 08436020767470, 08436020768026

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2360-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2360-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-04	2019-08-23

Product code MEB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)