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Terminated

"***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.

FDA Recall Z-2601-2011 · Posted 2011-06-21

Recalling FirmLeventon S. A. U.
Recall StatusTerminated
Product CodeLDR
Date Initiated2011-03-11
Date Terminated2011-06-28
Product Quantity1000 cases (50,000 units)

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.

Firm 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 [email protected]. Questions concerning this recall should be directed to the QA Manager at 00 34 93 8176316 or e- mail to [email protected].

Root Cause

Device Design

Distribution Pattern

Nationwide Distribution: FL only.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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