"***DOSI-FLOW 1 I.V. EXTENSION SET WITH I.V. FLOW REGULATOR REGULADOR DE CAUDAL PARA SETS DE INFUSION I.V.***REF 259-025

FDA device recall Z-2601-2011 · posted 2011-06-21 · Terminated

Recall details

Recalling firm

Leventon S. A. U.

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.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

LDR

Quantity affected

1000 cases (50,000 units)

Distribution

Nationwide Distribution: FL only.

Date initiated

2011-03-11

Date posted

2011-06-21

Date terminated

2011-06-28

Location

Sant Esteve Sesrovires Barcelona, Spain

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