Recall Z-2360-2019 ยท MEB Pump, Infusion, Elastomeric
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
| Date | May 23, 2019 |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.