Return Of Used Products; Limited Warranty - SORIN GROUP D901 DIDECO LILLIPUT Mode D'emploi

M. RETURN OF USED PRODUCTS
Should the user be dissatisfied with anything related to the quality of the product, the
product distributor or the authorized local SORIN GROUP ITALIA representative
should be notified.
All parameters considered critical by the user must be reported with particular care
and urgency. The following is the minimum information that should be provided:
 Detailed description of the event and, if pertinent, the conditions of the
patient;
Identification of the product involved;

 Lot number of the product involved;
Availability of the product involved;

All the indications the user considers useful in order to under stand the

origin of the elements of dissatisfaction.
SORIN GROUP ITALIA reserves the right to authorize, if necessary, recall of the
product involved in the notification for assessment. If the product to be returned is
contaminated, it must be treated, packed and handled in conformity with the
provisions of the legislation in force in the country where the product was used.
It is the responsibility of the health care institution to adequately prepare and
identify the product for return shipment. Do not return products that have been
exposed to blood borne infectious diseases.
ONLY for US customers
If for any reason the product must be returned to the manufacturer, a returned good
authorisation (RGA) number is required from Sorin Group USA cardiovascular Inc.
prior to shipping.
If the product has been in contact with blood or blood fluids, it must be thoroughly
cleaned and disinfected before packing. It should be shipped in either the original
carton or an equivalent carton to prevent damage during shipment, and it should be
properly labelled with an RGA number and an indication of the biohazardous nature of
the content in the shipment.
The shipping address for returned goods in the US is:
Sorin Group USA, Inc.
Returned CV Products
14401 West 65 Way
th
Arvada, CO 80004-3599
FAX (800) 323 4031.
N. LIMITED WARRANTY
This Limited Warranty is in addition to any statutory rights of the Purchaser pursuant
to applicable law.
SORIN GROUP ITALIA warrants that all reasonable care has been taken in the
manufacture of this medical device, as required by the nature of the device and the
use for which the device is intended.
SORIN GROUP ITALIA warrants that the medical device is capable of functioning as
indicated in the current instructions for use when used in accordance with them by a
qualified user and before any expiry date indicated on the packaging.
However, SORIN GROUP ITALIA cannot guarantee that the user will use the device
correctly, nor that the incorrect diagnosis or therapy and/or that the particular physical
and biological characteristics of an individual patient, do not affect the performance
and effectiveness of the device with damaging consequences for the patient, even
though the specified instructions for use have been respected. SORIN GROUP
ITALIA, whilst emphasizing the need to adhere strictly to the instructions for use and
to adopt all the precautions necessary for the correct use of the device, cannot
assume any responsibility for any loss, damage, expense, incidents or consequences
arising directly or indirectly from the improper use of this device.
SORIN GROUP ITALIA undertakes to replace the medical device in the event that it
is defective at the time of placing on the market or whilst being shipped by SORIN
GROUP ITALIA up to the time of delivery to the final user unless such defect has
been caused by mishandling by the purchaser.
The above replaces all other warranties explicit or implicit, written or verbal, including
warranties of merchantability and fitness for pur-pose. No person, including any
representative, agent, dealer, distributor or intermediary of SORIN GROUP ITALIA or
any other industrial or commercial organization is authorized to make any
representation or warranty concerning this medical device except as expressedly
stated herein.
SORIN GROUP ITALIA disclaims any warranty of merchantability and any warranty of
fitness for purpose with regard to this product other than what is expressedly stated
herein.
The purchaser undertakes to comply with the terms of this Limited Warranty and in
particular agrees, in the event of a dispute or litigation with SORIN GROUP ITALIA,
not to make claims based on alleged or proven changes or alterations made to this
Limited Warranty by any representative, agent, dealer, distributor or other
intermediary.
The existing relations between the parties to the contract (also in the case that it is not
drawn up in writing) to whom this Warranty is given as well as every dispute related to
it or in any way connected to it as well as anything related to it or any dispute
concerning this Warranty, its interpretation and execution, nothing excluded and/or
reserved, are regulated exclusively by the Italian law and jurisdiction. The court
chosen is the Court of Modena (Italy).
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