SECURE® 66050Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00812496011596), received between Jan 9, 2025 and Jan 9, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Oct 9, 2024Open, Classified

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

   Z-0340-2025 · Root cause: Under Investigation by firm · Recall details · 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.

• MalfunctionJan 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER INITIALLY STATED, "OUR COMPOUNDING PHARMACIST LET US KNOW THAT THE 500ML EVA SECURE BAGS (REF 66050) ARE CONSISTENTLY LEAKING. THESE ONES WERE NOT PART OF THE RECALL FROM OCTOBER (THEY HAVE A "10" BETWEEN THE TWO PORTS)". UPON REQUEST FOR ADDITIONAL INFORMATION, THE CUSTOMER FURTHER REPORTED, "THE BAG WAS LEAKING FAIRLY VIGOROUSLY FROM THE BOTTOM OF THE BAG, ON THE OUTSIDE OF THE PORTS (SO, NOT IN BETWEEN THE PORTS). SHE THINKS, BUT IS NOT CERTAIN, THAT IT WAS THE SIDE OF THE BAG WITH THE ADDITION PORT. SHE WAS SPECIFIC THAT IT WAS A NUMBER 8 BAG." THIS LOT NUMBER (66050-A8460) WAS INVOLVED IN THE RECALL CORRECTION OF 2 PORT BAGS MANUFACTURED FROM 12/8/2023 TO 9/26/2024. PER RECALL PROCEEDINGS, THE FINISHED PRODUCT WAS SORTED AND REPACKAGED TO REMOVE CAVITY #6 FROM THE LOT. THE PRODUCT LEAK WAS IDENTIFIED BY THE FILLING PHARMACY, THUS NO PATIENT CONTACT OR ADVERSE EVENT WAS REPORTED. NO SAMPLES OR IMAGES OF THE LEAKING PRODUCT WERE AVAILABLE TO REVIEW. 43 UNUSED SAMPLES WERE RETURNED FROM LOT 66050-A8460 FOR METRIX INVESTIGATION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21112098 ↗

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-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-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-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-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-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-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-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-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-0342-2025 · Oct 9, 2024 · Open, Classified
  Imed Products Imed EVA BAG, 150 mL, 2-PORTS, REF IM38040; 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-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.
• 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-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-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-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.

…and 1 more.