SECURE® 66043Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 50812496011577), received between Nov 20, 2020 and May 12, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Contamination” (3 reports).

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-0338-2025 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2021Contamination; Contamination

  IT WAS REPORTED THAT PARTICULATE WAS FOUND IN 2 TO POSSIBLY 9 UNITS OF THE SECURE 50 ML 2 PORT EVA BAGS, LOT 66043-A6591. LATER IT WAS REPORTED AN ADDITIONAL 9 UNITS WERE IDENTIFIED WITH PARTICULATE. THE PARTICULATE WAS NOTED BY THE SAME PHARMACY UPON INSPECTION AFTER THE BAGS WERE FILLED. THERE IS NO REPORT OF PATIENT INJURY OR DEATH. THE PARTICULATES ARE IN THE PROCESS OF BEING ANALYZED BY A THIRD PARTY LABORATORY. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11814968 ↗
• MalfunctionMay 12, 2021Contamination; Contamination

  IT WAS REPORTED THAT PARTICULATE WAS FOUND IN 3 TO POSSIBLY 10 UNITS OF THE SECURE 50 ML 2 PORT EVA BAGS, LOT 66043-A6929. LATER IT WAS REPORTED AN ADDITIONAL 3 UNITS WERE IDENTIFIED WITH PARTICULATE. THE PARTICULATE WAS NOTED BY THE SAME PHARMACY UPON INSPECTION AFTER THE BAGS WERE FILLED. THERE IS NO REPORT OF PATIENT INJURY OR DEATH. THE PARTICULATES ARE IN THE PROCESS OF BEING ANALYZED BY A THIRD PARTY LABORATORY. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11814890 ↗
• MalfunctionNov 20, 2020Contamination; Contamination

  IT WAS REPORTED THAT PARTICULATE WAS FOUND IN 11 UNITS OF THE SECURE 50 ML 2 PORT EVA BAGS, LOT 66043-A6389. THE PARTICULATE WAS NOTED BY THE SAME PHARMACY UPON THE INSPECTION OF THE BAGS AT THE TIME OF FILLING OR AFTER THE BAGS WERE FILLED. THERE IS NO REPORT OF PATIENT INJURY OR DEATH. THE PARTICULATES WERE ISOLATED BY A THIRD PARTY LAB AND ANALYZED VIA FTIR. THE RESULTS OF THE FTIR INDICATE THE PARTICULATES ARE MOST LIKELY RAYON, POLYESTER AND EVA. THE SOURCE OF THESE PARTICULATES IS ACTIVELY BEING INVESTIGATED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10874715 ↗

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

…and 1 more.