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U.S. Department of Health and Human Services

Class 2 Device Recall DOSIFLOW 1 I.V. EXTENSION SET

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  Class 2 Device Recall DOSIFLOW 1 I.V. EXTENSION SET see related information
Date Initiated by Firm March 11, 2011
Date Posted June 21, 2011
Recall Status1 Terminated 3 on June 28, 2011
Recall Number Z-2601-2011
Recall Event ID 59000
510(K)Number k851058  
Product Classification Controller, infusion, intravascular, electronic - Product Code LDR
Product "***DOSI-FLOW 1 I.V. EXTENSION SET WITH I.V. FLOW REGULATOR REGULADOR DE CAUDAL PARA SETS DE INFUSION I.V.***REF 259-0250***50 UNITS***STERILE OE***LATEX-FREE***LEVENTON LEVENTON, S.A.U. C/Newton, 18-24 08635 Sant Esteve Sesrovires BARCELONA-SPAIN***Distributed by: Victus www.victus.com 4918 S.W. 74th Court Miami, FL 33155***"

To control intravascular infusion of medication.
Code Information Lot numbers: 101444L and 101494L
Recalling Firm/
Manufacturer		 Leventon S. A. U.
C/ Newton, 18-24
Sant Esteve Sesrovires
Barcelona Spain
Manufacturer Reason
for Recall		 Leventon, S.A.U. Barcelona, Spain is recalling DOSI-FLOW REGULATOR, Part Number 259-0250, Lot Numbers 101444L and 101494L. Product has potential to leak.
FDA Determined
Cause 2		 Device Design
Action The firm, Leventon, S.A.U. sent an "URGENT: MEDICAL DEVICE RECALL" letter dated March 11, 2011 to the affected customer. The letter identifies the product, problem, and actions to be taken by the customer. The letter instructs the customer to examine their inventory and quarantine any product subject to the recall. They were also instructed to identify their customers who have received the product, notify them of the recall, send a copy of the recall notification letter and request that the customers return any unused product. The customers were also instructed to complete and return the attached RECALL RESPONSE FORM within 5 working days via fax to 00 34 93 6532556 or e-mail to dsalvatierra@leventon.es. Questions concerning this recall should be directed to the QA Manager at 00 34 93 8176316 or e- mail to dsalvatierra@leventon.es.
Quantity in Commerce 1000 cases (50,000 units)
Distribution Nationwide Distribution: FL only.
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.
510(K) Database 510(K)s with Product Code = LDR and Original Applicant = LEVENTON, S.A.
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