DOSI-FUSER recallZ-2360-2019 · Leventon S. A. U. · initiated May 23, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Leventon S. A. U. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The product lacks 510(k) clearance, and therefore is misbranded and must be removed from the U.S. market.
FDA root cause category: No Marketing Application
What the company is doing
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]
Recall details
- Recall number
- Z-2360-2019
- Status
- Terminated
- Initiated by the company
- May 23, 2019
- Recalling firm
- Leventon S. A. U.
- Quantity
- 1700
- Product code
- MEB
- Distribution
- US Distribution to states in: AZ, CA, MA, MI, PR, and FL.
Product description
DOSI-FUSER 12591 5-500D1 -USA, 12591 5-600D1 -USA Provide parenteral drug infusions at a constant flow without impeding patient mobility
Code information (models, lots, serial numbers)
172055L, 1721 10L, 1 807881, 181 1401 Unique Device Identifier (UDI) 08436020767470, 08436020768026
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- DOSI-FUSER L25915-500D1-USALeventon Sau · Pump, Infusion, Elastomeric1 recall0 reports
- DOSI-FUSER L25915-600D1-USALeventon Sau · Pump, Infusion, Elastomeric1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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