FDA-Device2024-11-20Class II
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.
The Metrix Company
Hazard
A limited number of IV bags have been found to leak during filling.
Sold states
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.
Affected count
288 cases of 50 units
Manufactured in
4400 Chavenelle Rd, N/A, Dubuque, IA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0330-2025Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief