LeMaitre Pruitt F3 Mode D'emploi page 6

Storage Shelf Life
The shelf life is indicated by the USE BY date on the package label. The USE BY date printed on each label is NOT a sterility date. The USE
BY date is based on the normal life expectancy of the natural rubber latex balloon when properly stored. The use of the shunt beyond
the expiration date is not recommended because of potential balloon deterioration. LeMaitre Vascular, Inc. does not make provisions
for replacing or reprocessing expired product.
Since natural rubber latex is affected by environmental conditions, proper storage procedures must be practiced to achieve optimum
shelf life. The product should be stored in a cool dark area away from fluorescent lights, sunlight, and chemical fumes to prevent
premature deterioration of the rubber balloon. Proper stock rotation should be practiced.
Resterilization/Re-use
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 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.
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.
References
1. Dainko EA. Complications of the use of the Fogarty Balloon. Catheter Arch Surgery, 105:79-82, 1972.
2. Cranley JJ, Krause ES, Strausser CC, Hafner A, Complication With the Use of the Fogarty Balloon Catheter for Arterial
Embolectomy J. Cardiovas Surgery, Volume 10, September-October 1969. Pp. 407-409.
3. Debakey M. Gooto A. The Living Heart. 1977, pp. 144-153
4. A Foster JH et al, Arterial Injuries Secondary to Use of the Fogarty Catheter Arr Surgery, 171: 971-978, 1970.
5. Ochlert WH. A Complication of the Fogarty Arterial Embolectomy Catheter AM Heart J, 84:484-486, 1972.
6. Pruitt JC. 1009 Consecutive Carotid Endarterectornies Local Anesthesia, EEG, and Selective Shunting with Pruitt-Inahara
Carotid Shunt Contemporary Surgery, Vol. 23, Sept 1983.
7. Pruitt JC, Morales RE. Carotid Endarterectomy: A Report of 7,854 Procedures Using Local Anesthesia,
Electroencephalographic Monitoring, Occlusion Catheters and the Pruitt-Inahara Carotid Shunt Surgical Technology
International IV, 1995.
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