Z-0343-2025 Class II Ongoing

Recalled by The Metrix Company — Dubuque, IA

Recall Details

Product Type
Devices
Report Date
November 20, 2024
Initiation Date
October 9, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1056 cases of 50 units

Product Description

Imed Products Imed EVA BAG, 250 mL, 2-PORTS, REF IM68045; 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 Pattern

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.

Code Information

UDI/DI 00812496011312, Lot Numbers: 68045-A8289, 68045-A8319, 68045-A8347, 68045-A8390, 68045-A8434