Recall Z-0344-2025— The Metrix Company

Name: FDA recall Z-0344-2025
Creator: U.S. Food and Drug Administration
Published: 2024-10-09

Class II · Ongoing

Class II FDA medical device recall by The Metrix Company, initiated 2024-10-09. It names one FDA 510(k) clearance: K030888. Product: Imed Products Imed EVA BAG, 500 mL, 2-PORTS, REF IM68050; 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..

Recalling firm: The Metrix Company
Classification: Class II
Status: Ongoing
Initiated: 2024-10-09
Firm location: Dubuque, IA, United States

510(k) clearances named in this recall

1 on FDA's record

K030888 — EVA EMPTY SOLUTION CONTAINERMetrix Co.·cleared 2003-04-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Imed Products Imed EVA BAG, 500 mL, 2-PORTS, REF IM68050; 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.