Device 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.
Z-0344-2025
Product summary
- Event
- Event 95499
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 864 cases of 50 units
- Official record key
device-enforcement:Z-0344-2025
Official wording
Reason: A limited number of IV bags have been found to leak during filling.
Code information: UDI/DI 00812496011329, Lot Numbers: 68050-A8320, 68050-A8435, 68050-A8476
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.
Derived failure modes
-
Unknown
A limited number of IV bags have been found to leak during filling.