At Hollister Incorporated, patient safety is our top priority. We strive to deliver products that meet the most rigorous safety and quality standards across the industry. We want you to have the utmost confidence that our products have been thoroughly tested and meet appropriate regulatory standards. FREQUENTLY ASKED QUESTIONS: Are Hollister Intermittent Catheters safe for my patients? Yes, Hollister products are safe. Our products are FDA cleared and/or EU approved. Do Hollister Intermittent Catheters contain harmful chemicals? No, Hollister intermittent catheters are not harmful. Our intermittent catheters are not manufactured with natural rubber latex or phthalates, which may be harmful. Some products are PVC free. Does that make them safer? No, not necessarily. There is no data to support that PVC alone is harmful. What is known is that additives such as DEHP, and other phthalates may increase the risk posed to human health. That is why Hollister has chosen not to manufacture their intermittent catheters with phthalates. Hollister intermittent catheters contain non-phthalate plasticizers that have been tested and are safe for use in medical products. What plasticizer do Hollister Intermittent Catheters contain? Hollister uses a plasticizer that is not manufactured with phthalates. Also, our products contain plasticizers that comply with the European REACH regulation, and are not found on the Substitute It Now (SIN) list. Where can I get more information about product safety? Please visit www.hollister.com. Glossary of Terms FDA: The Food and Drug Administration (FDA or USFDA) is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products. Phthalates: Phthalate esters, are esters of phthalic acid. They are mainly used as plasticizers, i.e., substances added to plastics to increase their flexibility, transparency, durability, and longevity. They are used primarily to soften polyvinyl chloride (PVC). PVC: Also known as polyvinyl or vinyl, commonly abbreviated PVC, is the world's third-most widely produced synthetic plastic polymer, after polyethylene and polypropylene. DEHP: Bis(2-ethylhexyl) phthalate (di-2-ethylhexyl phthalate, diethylhexyl phthalate, DEHP; dioctyl phthalate, DOP) is an organic compound with the formula C6H4(CO2C8H17)2. DEHP is the most common member of the class of phthalates, which are used as plasticizers. Plasticizers: (UK: plasticisers) or dispersants are additives that increase the plasticity or viscosity of a material. These are the substances which are added in order to alter their physical properties. These are either liquids with low volatility or may be even solids. They decrease the attraction between polymer chains to make them more flexible. REACH: Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) is a European Union regulation dating from 18 December 2006. REACH addresses the production and use of chemical substances, and their potential impacts on both human health and the environment. It is the strictest law to date regulating chemical substances and will affect industries throughout the world. SIN List: The SIN (Substitute it Now!) List is a globally used database of chemicals likely to be banned or restricted in a near future. The chemicals on the SIN List have been identified by ChemSec (International Chemical Secretariat) as Substances of Very High Concern (SVHC) based on the criteria established by the EU chemicals regulation REACH.