Device product
CORMIX 250 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64045; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Z-0333-2025
Product summary
- Event
- Event 95499
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3456 cases of 50 units
- Official record key
device-enforcement:Z-0333-2025
Official wording
Reason: A limited number of IV bags have been found to leak during filling.
Code information: UDI/DI 00812496011121, Lot Numbers: 64045-A8305, 64045-A8341, 64045-A8366, 64045-A8377, 64045-A8405, 64045-A8411, 64045-A8447, 64045-A8469, 64045-A8485
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.