DOSI-FLOW 1 I.V. EXTENSION SET WITH I.V. FLOW REGULATOR… recallZ-2601-2011 · Leventon S. A. U. · initiated Mar 11, 2011
Terminated All recalls posted in June 2011
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Leventon S. A. U. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Device Design
What the company is doing
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].
Recall details
- Recall number
- Z-2601-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Mar 11, 2011
- Posted by the FDA
- Jun 21, 2011
- Recalling firm
- Leventon S. A. U.
- Quantity
- 1000 cases (50,000 units)
- Product code
- LDR
- FDA submissions
- K851058
- Distribution
- Nationwide Distribution: FL only.
Product description
"***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 (models, lots, serial numbers)
Lot numbers: 101444L and 101494L
Other devices under the same FDA submission
2 devices cleared under K851058 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Rate Flow® L2590260-US5300Leventon Sau · Set, Administration, Intravascular10 reports
- Rate Flow® L2590263-V5922Leventon Sau · Set, Administration, Intravascular4 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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