FDA Medical Device Recalls (openFDA)
Leventon S. A. U.: DOSI-FUSER 12591 5-500D1 -USA, 12591 5-600D1 -USA Provide parenteral drug infusions at a constant flow without impeding patient mobility
- Recall number
- Z-2360-2019
- 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
- Status
- Terminated
- Initiated
- 2019-05-23
- Posted
- not on file
- Terminated
- 2020-06-08
- Reason
- The product lacks 510(k) clearance, and therefore is misbranded and must be removed from the U.S. market.
- 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 : dsalvatierra@leventon.es
- Quantity
- 1700
- Distribution
- US Distribution to states in: AZ, CA, MA, MI, PR, and FL.
- Lot, serial or model codes
- 172055L, 1721 10L, 1 807881, 181 1401 Unique Device Identifier (UDI) 08436020767470, 08436020768026
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MEB
- Firm FEI
- 3002807471
- Firm city
- Sant Esteve Sesrovires Barcelona
- Firm state
- not on file
- Firm country
- Spain
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28