Device product
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.
Z-0343-2025
Product summary
- Event
- Event 95499
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1056 cases of 50 units
- Official record key
device-enforcement:Z-0343-2025
Official wording
Reason: A limited number of IV bags have been found to leak during filling.
Code information: UDI/DI 00812496011312, Lot Numbers: 68045-A8289, 68045-A8319, 68045-A8347, 68045-A8390, 68045-A8434
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.