SECURE® 66215Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00812496011718), received between Jul 21, 2021 and Jul 14, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (2 reports).

17 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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A CONTAMINANT WAS FOUND IN ONE UNIT OF AN EMPTY IV BAG AFTER POOLING SEVERAL IVIG PRODUCTS TOGETHER. THIS WAS NOTED BY THE PHARMACY AFTER COMPOUNDING. THERE WAS NO PATIENT INVOLVEMENT. THE CONTAMINANT WAS DESCRIBED BY THE PHARMACY AS AN APPROXIMATELY 1 CM TRANSLUCENT STRAND .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15014054 ↗
• MalfunctionJul 21, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A FIBER-LIKE PARTICULATE WAS FOUND IN AN EMPTY SECURE 1000 ML LEGLESS EVA BAG WITH FEMALE CONNECTOR. THE PARTICULATE WAS NOTED BY THE PHARMACY PRIOR TO FILLING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12206609 ↗

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-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-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-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-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-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-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-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-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-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-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-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-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-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.

…and 2 more.