STATEMENT OF COMPLIANCE
VORTRAN® Medical Technology, Inc. is registered with the U.S. Federal Food and Drug Administration (FDA) and the California State Food and Drug Branch (FDB) as a medical device manufacturer. Annual audits by both the FDA and FDB ensure compliance with “Current Good Manufacturing Practice” (CGMP, 21 C.F.R. Code of Federal Regulation) and the Safe Medical Devices Act of 1990. The design of our devices is reviewed by the FDA as required by the 21 C.F.R. Section 510(k) to ensure that our devices are safe and efficacious. Consistent product quality is assured through our comprehensive Quality Assurance Program certified under ISO 13485:2003. Our goal is to exceed our customers’ expectations and to provide products and service of the highest quality.VORTRAN® Medical has also obtained the CE certification to sell in the European Union with our certification being audited by TUV SUD America.
VORTRAN® Medical Technology, Inc. is dedicated to achieving and sustaining consistent quality through the design and manufacturing of products that meet the needs of the worldwide medical market and the expectations of our customers.
Our objectives will be achieved through…
- Continuous improvements in an enhanced quality system and the teamwork of employees and distributors.
- Implementing and following a quality management system that meets the requirements of ISO 13485 in order to comply with customer requirements.
- Commitment to meeting applicable national and regional regulatory requirements.
- Communication of this policy to employees.
- Reviewing quality objectives and implementing improvements.
SHELF LIFE STATEMENT
The VORTRAN Automatic Resuscitator (VAR® device ) is 510(k) approved and is FDA classified as a “short term emergency non-continuous ventilator.”
The recommended shelf life for the VAR® device is five years from the date of manufacture. This five year recommendation is due to the possible breakdown of the vinyl tubing that is packaged with the VAR® device.
Since the VAR® device is made of plastic and SS302 stainless steel springs, there is no expectation that the VAR® device will degrade when stored at room temperature (-40° to 60° C). Vinyl tubing, on the other hand, has an atomic life and breaks down every day. This tubing has been known to harden and lose its flexibility. It can also become oily to the touch. To avoid these possibilities, we highly recommend that the VAR device device be used on a regular basis.
If the tubing included with the VAR® device does go out-of-date, we can replace the oxygen tubing with Part # 2187-20. We advise that you keep the new tubing with your stocked VAR® devices so that both will be ready for use when needed.
Unless otherwise indicated, the shelf life for our disposable VAR® device is five (5) years from the date of manufacture when stored under proper environmental conditions.
VORTRAN® Medical Technology, Inc. manufactures respiratory medical products and is committed to meeting all regulatory requirements to achieve the highest quality. All of our products are manufactured in Sacramento, California, USA under strict quality control guidelines. We use only the best materials available to ensure your satisfaction. Our products are produced from certified latex-free materials of the highest quality molded and/or extruded medical grade thermoplastic resin available, such as high density polyethylene, styrene-butadiene copolymers, flexible PVC, silicon rubber, and SS302 stainless steel springs.
According to the vendor of the flexible PVC used in the oxygen supply tubing, the exudation one may experience is a natural phenomenon that occurs with all flexible vinyl compounds. When exposed to high temperatures, high humidity, or sunlight, the plasticizers present in the tubing can migrate to the surface of the tubing, creating an oily film. However, this film does not indicate a harmful degradation or breakdown of the product. These conditions can also cause discoloration or stiffness in the product. The vendor states that proper stock rotation, using a “First In First Out” process, will minimize the likelihood of exposure to such environmental conditions. High heat, humidity and prolonged exposure to intense ultraviolet light will not cause an inability of the tubing to perform, but may cause a loss of cosmetic quality.
LIMITED WARRANTY STATEMENT
A. Distributor shall promptly inform the Company of all information obtained by Distributor relating to any claimed or actual defect or deficiency in any of the Company’s Product. In no event shall Distributor attempt to repair or correct a defect or deficiency in any Company product, or advise any other person to do so, without the expressed authorization of the Company. In all cases involving such defects or deficiencies, Distributor shall proceed as instructed by the Company. However, Distributor must comply with all applicable laws and regulations including but not limited to the regulations of the FDA as they apply to Medical Devices.
B. The Company warrants that their products will conform to published specifications and be free from defects in material or workmanship for a period of six (6) months from the date of delivery. This warranty is expressly conditioned upon the following: the Company’s Products, and all parts therefor, have been used, stored, installed, maintained, and operated in accordance with the Company’s instructions and standard industry practice, and that there as been no misuse, modification, substitution or alteration of the Company Products or any parts therefor.
C. All warranty authorization decisions are made by the Company, and the Company shall address any warranty authorizations by suitable repair or replacement.
D. THE COMPANY MAKES NO OTHER WARRANTY OF ANY KIND WITH RESPECT TO COMPANY PRODUCTS. ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING BUT NOT LIMITED TO, IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, ARE HEREBY DISCLAIMED.
VORTRAN® Medical Technology, Inc. is committed to providing our customers with the highest level of service and support. If you have a specific question or concern, please contact us directly via email at email@example.com, or by phone at (800) 434-4034, or by fax (916) 648-9751.Our knowledgeable Customer Service team can provide answers or clarification to the following product and company inquiries:
RETURN GOODS POLICY
All returns must be accompanied by a Returned Goods Authorization (RGA) number. To obtain an RGA number, contact Customer Service at (800) 434-4034.The following information is needed to request an authorization:
- Reason for return
- Date of purchase
- Invoice or PO number
- Product order and control number
- Quantity to return
All authorized returns must be made within sixty (60) days of the invoice date and be accompanied by the appropriate purchase order number and RGA number.
ALLOWABLE SCHEDULE FOR AUTHORIZED RETURN
- Orders processed in error by VORTRAN® Medical will be credited in full
- Defective products will be credited in full
- Unless defective or shipped in error, any return accepted is subject to a 15% restocking fee (minimum charge of $10.00)
- All returned products are subject to VORTRAN® Medical’s inspection and acceptance
- Product must be shipped prepaid
NON-RETURNABLE, OTHER THAN FOR A MANUFACTURING DEFECT
- Products discontinued by VORTRAN® Medical
- Products engraved, etched or labeled by hospital
- Returns more than sixty (60) days past invoice date
- Custom, special or modified products
- Plastic packaging of products is opened
- Products damaged beyond repair, refurbishment or not in resalable condition
SERVICE & SUPPORT:
- Technical Support
- Order Status
- Partial Shipments and Special Orders
- Problems or Complaints
- Refurbishment or Repair Services
- Product Warranty Procedures