Class II
Medical Device Recall: 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 · October 9, 2024
Reason for Recall
A limited number of IV bags have been found to leak during filling.
Distribution
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.
States Affected
NATIONWIDE
Quantity Affected
288 cases of 50 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0330-2025
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.