Mix2Vial Transfer Device 8074001Recalls & reported problems
West Pharma. Services Il, . Ltd · Mix2vial 20/20 · 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 07290108240672), received between Dec 12, 2024 and Dec 23, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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.
Reports received per month
Most reported problems
Device problems
- Contamination /Decontamination Problem1
- Delivered as Unsterile Product1
- Device Damaged Prior to Use1
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.
MalfunctionDec 23, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
THE CUSTOMER, PFIZER, CONTACTED THE DEVICE MANUFACTURER ON 01DEC2025 TO REPORT THAT DURING PRODUCTION, FOREIGN MATERIAL WAS OBSERVED BY A PACKAGING TECHNICIAN INSIDE A SEALED, STERILE MIX2VIAL DEVICE. THE VISUAL INSPECTION OF THE FOREIGN MATERIAL APPEARED TO BE A PIECE OF A WHITE GLOVE. THE SEALED DEVICE WAS SENT TO THE CUSTOMER'S IN-HOUSE LAB FOR TESTING WHICH CONFIRMED THAT THE FOREIGN MATERIAL WAS PART OF A NITRILE GLOVE. AS THE DEVICE HAD NOT YET ENTERED INTO THE DISTRIBUTION STAGE TO THE END USER (I.E. BEING PUT INTO SERVICE), THERE WAS NO HEALTH IMPACT TO THE END USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23878150 ↗MalfunctionDec 12, 2024Delivered as Unsterile Product; Device Damaged Prior to Use; Delivered as Unsterile Product; Device Damaged Prior to Use
ON 15NOV2024, THE CUSTOMER, PFIZER INC. CONTACTED THE MANUFACTURER TO REPORT THAT ONE (1) BOX CONTAINING A SHIPMENT OF 300 MIX2VIAL TRANSFER DEVICES, LOT# J966, WAS DELIVERED DAMAGED, EXPOSING THE DEVICES INSIDE THE BOX AND BREACHING STERILITY OF THE DEVICES. THERE WAS NO HEALTH IMPACT TO THE END USER AS THIS ISSUE WAS DETECTED PRIOR TO USE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20919007 ↗
Other Set, I.V. Fluid Transfer devices
- EXACTAMIX H938740Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall1,350 reports
- EXACTAMIX H938738Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall1,180 reports
- EXACTAMIX H938739Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall972 reports
- EXACTAMIX H938741Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall710 reports
- EXACTAMIX H938737Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall607 reports
- EXACTAMIX H938724Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall513 reports
- EXACTAMIX H938173Baxter Healthcare Corporation · Set, i.V. Fluid transfer2 recalls260 reports
- EXACTAMIX H938176Baxter Healthcare Corporation · Set, i.V. Fluid transfer2 recalls232 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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