| Class 2 Device Recall DOSIFUSER | |
Date Initiated by Firm | May 23, 2019 |
Create Date | August 23, 2019 |
Recall Status1 |
Terminated 3 on June 08, 2020 |
Recall Number | Z-2360-2019 |
Recall Event ID |
83017 |
Product Classification |
Pump, infusion, elastomeric - Product Code MEB
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Product | DOSI-FUSER 12591 5-500D1 -USA, 12591 5-600D1 -USA
Provide parenteral drug infusions at a constant flow without impeding patient mobility |
Code Information |
172055L, 1721 10L, 1 807881, 181 1401 Unique Device Identifier (UDI) 08436020767470, 08436020768026 |
Recalling Firm/ Manufacturer |
Leventon S. A. U. Calle Newton 18 24 Sant Esteve Sesrovires Barcelona Spain
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Manufacturer Reason for Recall | The product lacks 510(k) clearance, and therefore is misbranded and must be removed from the U.S. market. |
FDA Determined Cause 2 | 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 in Commerce | 1700 |
Distribution | US Distribution to states in: AZ, CA, MA, MI, PR, and FL. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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