Recall Z-2601-2011 ยท LDR Controller, Infusion, Intravascular, Electronic
Leventon S. A. U.
"***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.
| Date | Jun 21, 2011 (initiated Mar 11, 2011) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 a |
| Quantity | 1000 cases (50,000 units) |
| Distribution | Nationwide Distribution: FL only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K851058 | DOSI FLOW Leventon, S.A., Apr 29, 1985 |