Leventon S. A. U. Calle Newton 18 24 Sant Esteve Sesrovires Barcelona Spain DOSI-FUSER 12591 5-500D1 -USA, 12591 5-600D1 -USA Provide parenteral drug infusions at a constant flow without impeding patient mobility Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
DOSI-FUSER 12591 5-500D1 -USA, 12591 5-600D1 -USA Provide parenteral drug infusions at a constant flow without impeding patient mobility
Brand
Leventon S. A. U. Calle Newton 18 24 Sant Esteve Sesrovires Barcelona Spain
Lot Codes / Batch Numbers
172055L, 1721 10L, 1 807881, 181 1401 Unique Device Identifier (UDI) 08436020767470, 08436020768026
Products Sold
172055L, 1721 10L, 1 807881, 181 1401 Unique Device Identifier (UDI) 08436020767470, 08436020768026
Leventon S. A. U. Calle Newton 18 24 Sant Esteve Sesrovires Barcelona Spain is recalling DOSI-FUSER 12591 5-500D1 -USA, 12591 5-600D1 -USA Provide parenteral drug infusions at a constant due to The product lacks 510(k) clearance, and therefore is misbranded and must be removed from the U.S. market.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The product lacks 510(k) clearance, and therefore is misbranded and must be removed from the U.S. market.
Recommended Action
Per FDA guidance
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 : dsalvatierra@leventon.es
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, FL, IN, MA, MI, PR
Page updated: Jan 10, 2026