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Recall Observatory FDA recall evidence

Device product

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.

Z-0343-2025

October 09, 2024

Class II

Product summary

Firm
The Metrix Company
Event
Event 95499
Status
Ongoing
Classification
Class II
Quantity
1056 cases of 50 units
Official record key
device-enforcement:Z-0343-2025

Official wording

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

Code information: UDI/DI 00812496011312, Lot Numbers: 68045-A8289, 68045-A8319, 68045-A8347, 68045-A8390, 68045-A8434

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.