Mix2Vial Transfer Device 8074022Recalls & reported problems
West Pharma. Services Il, . Ltd · Mix2Vial 20/20mm W/20mic large filter TG S-Spike · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07290108240429), received between Apr 21, 2023 and Feb 25, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Particulates” (2 reports).
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
- Particulates2
- Contamination1
- Delivered as Unsterile Product1
- Inadequate Filtration Process1
- Manufacturing, Packaging or Shipping Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 25, 2026Delivered as Unsterile Product; Manufacturing, Packaging or Shipping Problem
THE CUSTOMER, TAKEDA PHARMACEUTICALS, CONTACTED THE DEVICE MANUFACTURER ON 28TH JANUARY 2026 TO REPORT THAT DURING INCOMING INSPECTION, ONE DEVICE WAS IDENTIFIED WITH A PARTIALLY OPENED SEAL NEAR A CREASE ON THE BLISTER PACK SEAL CONTACT AREA. THIS PRESENTS A POTENTIAL BREACH TO THE STERILITY OF THE DEVICE. THIS DEFICIENCY WAS FOUND PRIOR TO USE. 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 24444260 ↗MalfunctionFeb 11, 2026Particulates
DURING A ROUTINE REVIEW OF THE MAUDE DATABASE, AN MDR THAT IS RELEVANT TO THE MANUFACTURER'S DEVICE HAS BEEN IDENTIFIED. IT WAS REPORTED BY A NURSE THAT DURING DRUG PREPARATION, WATER FOR INJECTION COULD NOT BE TRANSFERRED INTO THE DRUG VIAL. THE ISSUE OF "NO DILUENT TRANSFER" WAS ANALYZED BY THE PHARMACEUTICAL CUSTOMER'S LAB. DURING SAMPLE EXAMINATION OF THE COMPLAINT IN THE LAB, PARTICLES WERE OBSERVED ON THE DILUENT SPIKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24314500 ↗MalfunctionFeb 11, 2026Particulates; Inadequate Filtration Process
DURING A ROUTINE REVIEW OF THE MAUDE DATABASE, AN MDR SUBMITTED BY THE PHARMACEUTICAL CUSTOMER THAT IS RELEVANT TO THE MANUFACTURER'S DEVICE HAS BEEN IDENTIFIED. THE REPORT INDICATED THAT WHILE USING THE MIX2VIAL DEVICE TO RECONSTITUTE A LYOPHILISED DRUG PRODUCT, PARTICULATE MATTER WAS OBSERVED FLOATING WITHIN THE SYRINGE. THE PHARMACEUTICAL CUSTOMER REPORTED THAT THE SAMPLE WAS NOT RETURNED FOR ANALYSIS AND AFTER REVIEW OF THE PHOTOS PROVIDED, THE REPORTED DEFECT COULD NOT BE VERIFIED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24314481 ↗MalfunctionApr 21, 2023Contamination; Contamination
ON 17-FEB-2022, THE WEST'S CUSTOMER, TAKEDA PHARMACEUTICAL COMPANY LIMITED, CONTACTED WEST IL TO REPORT THAT DURING INCOMING INSPECTION OF MIX2VIAL 20/20MM W/20 M LARGE FILTER TG, THE VISUAL INSPECTION FOUND ONE UNIT CONTAINING A FOREIGN MATERIAL WITHIN THE BLISTER PACKAGE OF THE DEVICE. WEST PHARMA. SERVICES IL, LTD. (WEST ISRAEL) INVESTIGATED THIS COMPLAINT. THE DEVICE WAS NOT RETURNED TO WEST IL FOR AN EVALUATION. HOWEVER, A PHOTOGRAPH OF THE DEVICE WAS PROVIDED TO WEST IL. THE FOREIGN MATERIAL WITHIN THE BLISTER PACKAGE WAS ANALYZED BY THE CUSTOMER AND CONFIRMED AS HAIR (BIOLOGIC) WHICH WAS IN DIRECT CONTACT WITH THE WEST IL PRODUCT. THIS WAS FOUND PRIOR TO PATIENT USE. THE COMPLAINT WAS RE-EVALUATED AND DEEMED AS REPORTABLE BASED ON A CLINICAL ASSESSMENT ON 23MAR2023.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16784659 ↗
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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