FDA-Device2024-11-20Class II

Imed Products Imed EVA BAG, 150 mL, 2-PORTS, REF IM38040; 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
768 units
Manufactured in
4400 Chavenelle Rd, N/A, Dubuque, IA, United States
Products
Imed Products Imed EVA BAG, 150 mL, 2-PORTS, REF IM38040; 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-0342-2025

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