EcoFLX™ Empty Mixing Container DMP0150Recalls & reported problems
Douglas Medical Products, Inc. · EcoFLX 150mL Empty IV Mixing Container (PVC-Free) · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10816415020437), received between Feb 23, 2022 and Jul 15, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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.
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Fluid/Blood Leak1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 15, 2022Leak/Splash
DOUGLAS MEDICAL PRODUCT ECOFLX EMPTY MIXING CONTAINERS HAVE HAD MULTIPLE MALFUNCTIONS OF LEAKING PARTIALLY OR ENTIRELY, BOTH IN PATIENT ROOMS AND IN MEDICATION ROOMS WHEN SPIKED. AT TIMES IT HAS OCCURRED WHILE SPIKING AND OTHER TIMES IT HAS OCCURRED AFTER BEING SPIKED, SPONTANEOUSLY LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15026315 ↗MalfunctionFeb 23, 2022Fluid/Blood Leak; Detachment of Device or Device Component
TWO INSTANCES OF THE TUBING ON CONTROLLED SUBSTANCE BAG FELL OUT CAUSING THE CONTENTS OF THE BAG TO SPILL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13584034 ↗
Other Container, I.V. devices
- INTRAVIA 2B8011Baxter International Inc. · CONTAINER, I.V.127 reports
- INTRAVIA 2B8012Baxter International Inc. · CONTAINER, I.V.119 reports
- APEX™ 2112531B. Braun Medical Inc. · CONTAINER, I.V.69 reports
- APEX™ 2112530B. Braun Medical Inc. · CONTAINER, I.V.66 reports
- INTRAVIA 2B8013Baxter International Inc. · CONTAINER, I.V.64 reports
- SECURE® 66040Metrix Company, The · Container, I.V.1 recall8 reports
- MICROTEK 1Microtek Medical LLC · CONTAINER, I.V.1 recall8 reports
- SECURE® 66045Metrix Company, The · Container, I.V.1 recall7 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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