FDA recall Z-0331-2025

The Metrix Company · Class II · device

Product

VYGON 250 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9602; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.

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.

Key facts

Status
Ongoing
Initiation date
2024-10-09
Report date
2024-11-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Dubuque, IA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0331-2025