Rexam Healthcare has received510(k) approval from the Food and Drug Administration (FDA) forSafe¹n¹SoundTM, its passive safety device for stakedprefilled syringes

The approval granted to Rexam by the FDA for its Safe'n'SoundTM device is the crowning achievement of significant investment and efforts in terms of design by the Rexam teams.

Aug 27, 2011

The aim of the project was to design a safety device that meets the current regulations in North America and in Europe. These regulations are aimed at protecting workers in the health sector from needle injuries and contamination from blood borne pathogens.

The fully passive Safe'n'SoundTM device provides effective protection against the risks of being pricked by a soiled needle, thanks to the protective sheath which activates automatically once the medicine has been administered.

This 510(k) approval shows Rexam's commitment to innovation, safety and quality and allows the product to be marketed in the United States.

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