NA 68040Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00812496011305), received between May 22, 2026 and May 22, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

16 other recalls cover devices cleared under the same FDA submission (K030888); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Oct 9, 2024Open, Classified

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

   Z-0342-2025 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2026Contamination /Decontamination Problem

  ON 22-APR-2026, FDA INFORMED MANUFACTURER OF THREE (3) MEDWATCH REPORTS FILED BY END-USER DESCRIBING 'GLASS-LIKE PARTICULATE' INSIDE A EVA BAG AFTER FILLING. THIS WAS SUBSEQUENT TO DISTRIBUTOR INFORMING MANUFACTURER OF SAME COMPLAINT ON 31-MAR-2026, BUT WITH NO RETURNED PRODUCT AVAILABLE FOR EVALUATION, A ROOT CAUSE ANALYSIS COULD NOT BE DETERMINED. AFTER RECEIPT OF FDA LETTERS, MANUFACTURER REACHED OUT TO END-USER FOR ADDITIONAL DETAILS AND ANOTHER REQUEST FOR PRODUCT RETURN. THIS REPORT SERVES A FOLLOW-UP TO MEDWATCH REPORT #S MW5186093, MW5186094, & MW5186095 WHICH PROVIDES DETAILS ON RETURNED PRODUCT INVESTIGATION (AFFECTED PRODUCT RECEIVED 15-MAY-2026).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25257347 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K030888. One submission often covers many models, so check the product and lot details in each record.

• Z-0344-2025 · Oct 9, 2024 · Open, Classified
  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 intravenous (IV) administration.
• Z-0337-2025 · Oct 9, 2024 · Open, Classified
  SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports, REF 66042; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
• Z-0340-2025 · Oct 9, 2024 · Open, Classified
  SECURE 500 mL EMPTY EVA CONTAINER With 2 Ports, REF 66050; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
• Z-0335-2025 · Oct 9, 2024 · Open, Classified
  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.
• Z-0341-2025 · Oct 9, 2024 · Open, Classified
  SECURE 1000 mL EMPTY EVA CONTAINER With 2 Ports, REF 66055; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
• Z-0331-2025 · Oct 9, 2024 · Open, Classified
  VYGON 250 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9602; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
• Z-0339-2025 · Oct 9, 2024 · Open, Classified
  SECURE 250 mL EMPTY EVA CONTAINER With 2 Ports, REF 66045; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
• Z-0333-2025 · Oct 9, 2024 · Open, Classified
  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.
• Z-0343-2025 · Oct 9, 2024 · Open, Classified
  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-0330-2025 · Oct 9, 2024 · Open, Classified
  VYGON 100 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9601; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
• Z-0334-2025 · Oct 9, 2024 · Open, Classified
  CORMIX 500 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64050; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
• Z-0345-2025 · Oct 9, 2024 · Open, Classified
  Imed Products Imed EVA BAG, 1000 mL, 2-PORTS, REF IM68055; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
• Z-0336-2025 · Oct 9, 2024 · Open, Classified
  SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed), REF 66041; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
• Z-0332-2025 · Oct 9, 2024 · Open, Classified
  CORMIX 150 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64040; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
• Z-0338-2025 · Oct 9, 2024 · Open, Classified
  SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed) , REF 66043; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.

…and 1 more.