Z-0333-2025 Class II Ongoing

Recalled by The Metrix Company — Dubuque, IA

Recall Details

Product Type
Devices
Report Date
November 20, 2024
Initiation Date
October 9, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3456 cases of 50 units

Product Description

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.

Reason for Recall

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

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.

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