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U.S. Department of Health and Human Services

Class 2 Device Recall DOSIFUSER

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  Class 2 Device Recall DOSIFUSER see related information
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
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
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
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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