Skip to content
Recall Observatory FDA recall evidence

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

October 09, 2024

Class II

Product summary

Firm
The Metrix Company
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

    reason.no_named_rule · v1.0.0

    A limited number of IV bags have been found to leak during filling.