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High RiskFDAfda-Z-0344-2025OTHER

Imed Products Imed EVA BAG, 500 mL, 2-PORTS, REF IM68050; An empty single-use pouch made of plastic intended to contain a fluid for intra...

Units Affected
864
Recall Date
October 9, 2024
Issuing Agency
Hazard
Other

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0344-2025.

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

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0344-2025.

Recall ongoing. Follow firm instructions.

🩺 Talk to your doctor or pharmacist

Product Recall Tracker does not provide medical advice. Any specific instructions about this medication or device come directly from the FDA notice above. Before making any change to your treatment:

  1. Do not stop, change, or discard your prescription on your own.
  2. Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
  3. Follow your clinician's guidance on whether to continue, switch, or return the product.
  4. If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
  5. For the official FDA notice, visit the FDA recalls page.

Consumer Contact (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0344-2025.

The Metrix Company

FDA

About the U.S. Food and Drug Administration

The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.

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📣 Report an adverse event to the FDA (MedWatch)

If you had an adverse reaction, side effect, or device malfunction from this medication or device, report it to the FDA through MedWatch. Talk to your doctor or pharmacist first — do not stop a prescription on your own. Reports help the FDA detect rare or emerging safety signals and can lead to label changes or recalls.

How to report to FDAFile a report at FDA

The Metrix Company Recall FAQ

The Metrix Company is the subject of a medical devices safety report: Imed Products Imed EVA BAG, 500 mL, 2-PORTS, REF IM68050; An empty single-use pouch made of plastic intended to contain a fluid for intra.... The notice was published on October 9, 2024 by the U.S. Food and Drug Administration (FDA). Approximately 864 units are potentially affected.