SECURE® 66616Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 20812496011477), received between Jun 2, 2021 and Apr 2, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (4 reports).

9 other recalls cover devices cleared under the same FDA submission (K960581); 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  CUSTOMER REPORTED PLASTIC FLOATERS IDENTIFIED IN PRODUCT AFTER COMPOUNDING FOR FOUR SAMPLES. THE PARTICULATE CONTAMINATION WAS IDENTIFIED AFTER COMPOUNDING BY THE PHARMACY, THUS THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE EVENT. SAMPLES WERE NOT AVAILABLE FOR RETURN. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19028901 ↗
• MalfunctionMar 15, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THERE WAS A LEAK IN THE MIDDLE LINE OF A 1500 ML EVA DUAL CHAMBER BAG. THIS WAS NOTED BY THE PHARMACY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16545932 ↗
• MalfunctionMar 3, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A BLACK MARK OR A FLOATER WAS FOUND IN THE TOP CHAMBER OF A SECURE EVA 1500 ML DUAL CHAMBER BAG. THIS WAS NOTED BY THE PHARMACY DURING COMPOUNDING. THERE WAS NO PATIENT INVOLVEMENT. THE PHARMACY FURTHER STATED THAT THEY BELIEVED THE BLACK MARK OR FLOATER DISSOLVED INTO THE MEDIA. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13659576 ↗
• MalfunctionFeb 25, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A RED-BROWN MARK WAS PRESENT ON THE UPPER CHAMBER OF A SECURE EVA 1500 ML DUAL CHAMBER BAG. THIS WAS NOTED BY THE PHARMACY DURING COMPOUNDING. THE PHARMACY STATED THE RED-BROWN MARK LOOKS TO BE EMBEDDED WITHIN THE PLASTIC AND CANNOT BE REMOVED THROUGH CLEANING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13599270 ↗
• MalfunctionFeb 25, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A BLACK MARK AND/OR FLOATER WAS FOUND INSIDE A SECURE EVA 1500 ML DUAL CHAMBER BAG. THIS WAS NOTED BY THE PHARMACY DURING COMPOUNDING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13598577 ↗
• MalfunctionJun 2, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A FLOATER WAS FOUND INSIDE A SECURE EVA DUAL CHAMBER 1500 ML BAG WITH 5 PORT MANIFOLD FILL SET. IT WAS FURTHER REPORTED THAT THE FLUID WAS FILTERED WITH A 0.2 MICRON FILTER, THE INTEGRITY TEST PASSED AND NO NEEDLE PUNCTURES WERE MADE TO THE BAG. THE FLOATER WAS NOTED BY THE PHARMACY DURING THE VISUAL INSPECTION OF THE FILLED BAG AT THE PACKAGING BENCH. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11925131 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K960581. One submission often covers many models, so check the product and lot details in each record.

• Z-0006-2020 · Sep 21, 2018 · Open, Classified
  SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 4000mL, REF 66641 (Canadian distribution) - Product Usage: For use in an intravenous admixture program. The empty container will
• Z-0002-2020 · Sep 21, 2018 · Open, Classified
  SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 3000mL, (legless) REF 66630 - Product Usage: For use in an intravenous admixture program. The empty container will be fil
• Z-0001-2020 · Sep 21, 2018 · Open, Classified
  SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 1500mL, (legless) REF 66615 - Product Usage: For use in an intravenous admixture program. The empty container will be fil
• Z-0005-2020 · Sep 21, 2018 · Open, Classified
  SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 3000mL, REF 66631 (Canadian distribution) - Product Usage: For use in an intravenous admixture program. The empty container will
• Z-0007-2020 · Sep 21, 2018 · Open, Classified
  ExactaMix, Model: H938901, EMPTY EVA DUAL CHAMBER CONTAINER With Screw Connectors, 500 ml/ 2500 ml, Baxter - Product Usage: For use in an intravenous admixture program. The empty
• Z-0008-2020 · Sep 21, 2018 · Open, Classified
  ExactaMix, Model: H938905, EMPTY EVA DUAL CHAMBER CONTAINER With Screw Connectors, 250 ml/ 1250 ml, Baxter - Product Usage: For use in an intravenous admixture program. The empty
• Z-0004-2020 · Sep 21, 2018 · Open, Classified
  SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 1500mL, REF 66616 (Canadian distribution) - Product Usage: For use in an intravenous admixture program. The empty container will
• Z-0003-2020 · Sep 21, 2018 · Open, Classified
  SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 4000mL, (legless) REF 66640 - Product Usage: For use in an intravenous admixture program. The empty container will be fil
• Z-2263-2016 · Jun 23, 2016 · Terminated
  Dual Chamber Container fill with gravity/attached transfer sets, 250 mL / 1250 mL, 300 mL / 1700 mL, 500 mL / 2500 mL, 500 mL / 3500 mL