LeMaitre Pruitt Instrucciones De Uso página 3

• Arteriovenous fistula formation
• Balloon rupture
• Tip separation with Fragmentation and Distal Embolization
• Renal insufficiency
• Paraplegia
• Death
Model
Maximum Liquid Capacity
Usable Length
Contents
Re-sterilization/Repackaging
This device is single-use only. Do not reuse, reprocess, or re-sterilize. The
cleanliness and sterility of the re-processed device cannot be assured. Reuse
of the device may lead to cross contamination, infection, or patient death.
The performance characteristics of the device may be compromised due to
reprocessing or re-sterilization since the device was only designed and tested
for single use. The shelf life of the device is based on single use only. If for any
reason this device must be returned to LeMaitre Vascular, place it in its original
packaging and return it to the address listed on the box.
Limited Product Warranty; Limitation of Remedies
LeMaitre Vascular, Inc. warrants that reasonable care has been used in the manufacture
of this device. Except as explicitly provided herein, LEMAITRE VASCULAR (AS USED IN
THIS SECTION, SUCH TERM INCLUDES LEMAITRE VASCULAR, INC., ITS AFFILIATES, AND
THEIR RESPECTIVE EMPLOYEES, OFFICERS, DIRECTORS, MANAGERS, AND AGENTS) MAKES
NO EXPRESS OR IMPLIED WARRANTIES WITH RESPECT TO THIS DEVICE, WHETHER ARISING
BY OPERATION OF LAW OR OTHERWISE (INCLUDING, WITHOUT LIMITATION, ANY IMPLIED
WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE) AND HEREBY
DISCLAIMS THE SAME. LeMaitre Vascular makes no representation regarding the
suitability for any particular treatment in which this device is used, which determination
is the sole responsibility of the purchaser. This limited warranty does not apply to the
extent of any abuse or misuse of, or failure to properly store, this device by the purchaser
or any third party. The sole remedy for a breach of this limited warranty shall be
replacement of, or refund of the purchase price for, this device (at LeMaitre Vascular's
sole option) following the purchaser's return of the device to LeMaitre Vascular. This
warranty shall terminate on the expiration date for this device.
IN NO EVENT SHALL LEMAITRE VASCULAR BE LIABLE FOR ANY DIRECT, INDIRECT,
CONSEQUENTIAL, SPECIAL, PUNITIVE, OR EXEMPLARY DAMAGES. IN NO EVENT WILL THE
AGGREGATE LIABILITY OF LEMAITRE VASCULAR WITH RESPECT TO THIS DEVICE, HOWEVER
ARISING, UNDER ANY THEORY OF LIABILITY, WHETHER IN CONTRACT, TORT, STRICT
LIABILITY, OR OTHERWISE, EXCEED ONE THOUSAND DOLLARS (US$1,000), REGARDLESS OF
WHETHER LEMAITRE VASCULAR HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH LOSS,
AND NOTWITHSTANDING THE FAILURE OF THE ESSENTIAL PURPOSE OF ANY REMEDY.
THESE LIMITATIONS APPLY TO ANY THIRD-PARTY CLAIMS.
A revision or issue date for these instructions is included on the back page of these
Instructions for Use for the user's information. If twenty-four (24) months has elapsed
between this date and product use, the user should contact LeMaitre Vascular to see if
additional product information is available.
Specifications
2103-36,
e2103-36
0.5 mL
One Catheter, One Syringe, 3 mL
2103-46,
e2103-46
0.5 mL
27 cm
2103-56,
e2103-56
1.0 mL