FDA Medical devices recall ·
CORMIX 250 mL EMPTY EVA CONTAINER With 2 Ports recall
- Recall number
- Z-0333-2025
- Date
- (initiated October 9, 2024)
- Company / brand
- The Metrix Company
4400 Chavenelle Rd, Dubuque, IA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 3456 cases of 50 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
A limited number of IV bags have been found to leak during filling.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI/DI 00812496011121, Lot Numbers: 64045-A8305, 64045-A8341, 64045-A8366, 64045-A8377, 64045-A8405, 64045-A8411, 64045-A8447, 64045-A8469, 64045-A8485
Distribution
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.
States: California Florida Illinois Massachusetts Maryland Michigan Ohio Pennsylvania Puerto Rico Texas Utah Washington
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0333-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.