FDAFDA · Food and drugs·Recall number Z-0343-2025
Imed Products Imed EVA BAG, 250 mL, 2-PORTS, REF IM68045; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Published November 20, 2024 · Recall initiated: October 9, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
A limited number of IV bags have been found to leak during filling.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- The Metrix Company
- Distributor
- 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.
- Lot
- UDI/DI 00812496011312, Lot Numbers: 68045-A8289, 68045-A8319, 68045-A8347, 68045-A8390, 68045-A8434
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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