SECURE® 66631Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 20812496011514), received between Feb 25, 2021 and Jun 16, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (3 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.

• MalfunctionJun 16, 2023Fluid/Blood Leak; Fluid/Blood Leak

  SMALL TEAR AT SEPARATOR BAR INSEAM THAT RESULTED IN A LEAK. IT WAS INDICATED BY PERSONNEL THERE WAS NO INDICATOR OF LEAK AT TIME OF FILLING OR SEVERAL BAG INSPECTIONS. UPON REMOVAL OF SEPARATOR BAR, TEAR WAS APPARENT AND BAG LEAKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17147820 ↗
• MalfunctionFeb 21, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A MARK THAT CANNOT BE REMOVED WAS PRESENT ON THE LIPID CHAMBER OF A SECURE EVA 3000 ML DUAL CHAMBER BAG. THIS WAS NOTED BY THE PHARMACY FILLING STAFF DURING MIXING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16407604 ↗
• MalfunctionAug 4, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A SMALL BLACK FLOATING PARTICLE WAS FOUND INSIDE A SECURE EVA DUAL CHAMBER BAG. IT WAS FURTHER REPORTED THAT A 0.2 MICRON FILTER WAS USED TO PUMP THE ORDER AND THAT THE FILTER INTEGRITY TEST PASSED. THE FLOATING PARTICLE WAS NOTED BY THE PHARMACY DURING THE PACKAGING PROCESS. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12277563 ↗
• MalfunctionJun 17, 2021Contamination /Decontamination Problem; Device Contamination with Chemical or Other Material; Scratched Material; Contamination /Decontamination Problem; Device Contamination with Chemical or Other Material; Scratched Material

  IT WAS REPORTED THAT A STAIN WAS EMBEDDED INSIDE THE LIPID CHAMBER OF A SECURE EVA DUAL CHAMBER 3000 ML BAG WITH 5 PORT MANIFOLD FILL SET. THE STAIN WAS NOTED IN THE FILLED BAG BY THE PHARMACY DURING THE PACKING PROCESS. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12017997 ↗
• MalfunctionMay 4, 2021Defective Device; Defective Device

  IT WAS REPORTED BY A PHARMACY TECHNICIAN THAT WHILE FILLING A SECURE EVA DUAL CHAMBER 3000 ML BAG, LOT 66631-A6597, A SMALL AMOUNT OF LIPIDS IN THE UPPER CHAMBER PREMATURELY MIGRATED INTO THE ADMIXTURE OF SOLUTIONS IN THE LOWER CHAMBER. THERE WAS NO PATIENT INVOLVEMENT. THE UNIT WAS RETURNED TO METRIX FOR EVALUATION. THE RESULTS OF THE INVESTIGATION ARE STILL PENDING. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11770308 ↗
• MalfunctionFeb 25, 2021Contamination; Contamination

  IT WAS REPORTED THAT A FLOATING PARTICLE WAS FOUND IN 1 UNIT OF THE SECURE 3000 ML DUAL CHAMBER EVA BAG WITH 5 PORT MANIFOLD FILL SET, LOT 66631-A6472. THE PARTICLE WAS NOTED BY THE PHARMACY DURING THE PACKING PROCESS AFTER FILLING THE BAG. THERE IS NO REPORT OF PATIENT INJURY OR DEATH. THE PARTICLE HAS BEEN ISOLATED FROM THE BAG AND HAS BEEN SENT TO AN EXTERNAL LAB FOR EVALUATION. THE SOURCE OF THE PARTICLE IS BEING ACTIVELY INVESTIGATED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11381803 ↗

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-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-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-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-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-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-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-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-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-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