Z-0335-2025 Class II Ongoing
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
- 2229 cases of 50 units
Product Description
SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports, REF 66040; 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 00812496011541, Lot Numbers: 66040-A8314, 66040-A8368, 66040-A8417, 66040-A8482