VYGON 100 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9601; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.

Reason: A limited number of IV bags have been found to leak during filling.

Code information: UDI/DI 00812496011008, Lot Numbers: 62040-A8375, 62040-A8432

Distribution pattern: Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.