Vial2Bag Advanced 20mm 6070030Recalls & reported problems
West Pharmaceutical Services Az, Inc. · Vial2Bag Advanced 20mm - Admixture Device · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10850022888011), received between Feb 27, 2023 and Aug 12, 2026 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (6 reports).
1 FDA recall record name this device's identifier, 1 still open.
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 18, 2026.
Reports received per month
Recalls naming this device
- Sep 24, 2024Class IIOpen, Classified
Due to packaging damage from heat exposure during shipping/transportation that may result in a breach in the sterile barrier.
Z-0283-2025 · Root cause: Environmental control · Recall details · FDA record ↗
Most reported problems
Device problems
- Contamination /Decontamination Problem6
- Contamination2
- Tear, Rip or Hole in Device Packaging2
Patient problems
- No Clinical Signs, Symptoms or Conditions9
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 12, 2026Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50222751 ↗MalfunctionJun 15, 2026
FROM STAFF: RN WAS MIXING ORDERED ANTIBIOTIC AND WHEN SECONDARY TUBING WAS SPIKED INTO TRANSFER DEVICE IT STARTED TO LEAK WHERE THE CLEAR PLASTIC PIECE ATTACHES TO THE WHITE PLASTIC PIECE. MEDICATION WAS WASTED AND A NEW VIAL WAS PREPARED, AND THE SAME LEAKING OCCURRED AGAIN IN THE SAME PLACE. REF#6070030, LOT#L857. TRANSFER DEVICE AND PACKAGING PLACED IN BIOHAZARD BAG AND PUT IN ANM MAILBOX IN CHARGE OFFICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25501211 ↗MalfunctionApr 2, 2026Contamination /Decontamination Problem
ON (B)(6) 2026, (B)(6) INC. CONTACTED THE MANUFACTURER TO REPORT THAT UPON OPENING THE PACKAGING OF THE VIAL2BAG ADVANCED® 20MM ADMIXTURE DEVICE, A NURSE OBSERVED THAT TWO DEVICES APPEARED TO HAVE DEBRIS WITHIN THEIR CONTAINERS. THERE WAS NO PATIENT INVOLVEMENT AND THERE WAS NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24766056 ↗MalfunctionApr 2, 2026Contamination /Decontamination Problem
ON (B)(6) 2026, (B)(6) INC. CONTACTED THE MANUFACTURER TO REPORT THAT UPON OPENING THE PACKAGING OF THE VIAL2BAG ADVANCED® 20MM ADMIXTURE DEVICE, A NURSE OBSERVED THAT TWO DEVICES APPEARED TO HAVE DEBRIS WITHIN THEIR CONTAINERS. THERE WAS NO PATIENT INVOLVEMENT AND THERE WAS NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24766035 ↗MalfunctionAug 20, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
ON (B)(6) 2025, PROGRESSIVE MEDICAL INC. CONTACTED THE MANUFACTURER TO REPORT THAT UPON OPENING THE PACKAGING OF THE VIAL2BAG ADVANCED® 20MM ADMIXTURE DEVICE, A NURSE AT A HOSPITAL OBSERVED MOLD ON THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT AND THERE WAS NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22850489 ↗MalfunctionSep 3, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
ON 7AUG2024, DISTRIBUTOR, PROGRESSIVE MEDICAL INC., REPORTED THAT UPON OPENING A BOX OF VIAL2BAG ADVANCED® 20MM ADMIXTURE DEVICES, 9 UNITS IN A BOX OF 50 WERE OBSERVED WITH DAMAGED PRIMARY PACKAGING BREACHING STERILITY. THE VIAL2BAG DEVICES WERE NOT USED AND THERE WAS NO HARM TO REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20126769 ↗MalfunctionSep 3, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
ON 08AUG2024, WEST PHARMA SERVICES DISTRIBUTOR, (B)(4)., CONTACTED WEST PHARMA. SERVICES, IL LTD. (B)(6), TO REPORT THAT UPON OPENING A BOX OF VIAL2BAG ADVANCED¿ 20MM DEVICES, SEVERAL PACKAGES WERE NOT PROPERLY SEALED AND APPEAR TO HAVE GAPS IN THE GLUE. THE CUSTOMER INSPECTED 2 BOXES AND HAS 3 UNOPENED BOXES OF LOT K194 THAT THEY DO NOT WANT TO USE. THE CUSTOMER ALSO NOTED THAT THEY HAVE 61 INDIVIDUAL PACKAGES OF THE SAME LOT. HOWEVER, NOT ALL OF THESE 61 INDIVIDUAL PACKAGES ARE OPENED BY THE CUSTOMER. THE VIAL2BAG DEVICES WERE NOT USED AND THERE WAS NO HARM TO REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20126114 ↗MalfunctionApr 16, 2024Contamination; Contamination /Decontamination Problem; Contamination; Contamination /Decontamination Problem
ON 20MAR2024, (B)(6). CONTACTED WEST PHARMACEUTICAL SERVICES, INC. (WEST), TO REPORT THAT ON 19MAR2024, A MATERIALS MANAGER AT A HOSPITAL NOTICED THAT ONE OF THE UNOPENED VIAL2BAG ADVANCED® 20MM ADMIXTURE DEVICE BLISTER PACK APPEARED TO HAVE A FOREIGN DIRT-LIKE SUBSTANCE INSIDE OF IT AND ON THE VIAL2BAG DEVICE. THE PRODUCT WAS NOT OPENED, NOR WAS IT USED. THERE WAS NO HARM TO ANY PATIENT OR STAFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19115714 ↗MalfunctionFeb 27, 2023Contamination; Contamination /Decontamination Problem; Contamination; Contamination /Decontamination Problem
ON (B)(6) 2022, PROGRESSIVE MEDICAL, INC. CONTACTED WEST PHARMACEUTICAL SERVICES, INC. (WEST), TO REPORT A COMPLAINT FROM A CUSTOMER THAT UPON OPENING A VIAL2BAG ADVANCED® 20MM ADMIXTURE DEVICE, LOT NUMBER F427, THE SPIKE PORTION WAS FOUND TO BE CONTAMINATED. IT WAS REPORTED THAT THE DEVICE IS USED FOR UNIT MIXING OF INTRAVENOUS (IV) PIGGYBACKS. TWO OTHER PACKAGES WERE OPENED WITH THE SAME LOT AND EXPIRY DATE AND BOTH WERE VISIBLY CLEAN AND APPEARED UNCONTAMINATED. THE COMPLAINT WAS RE-EVALUATED AND DEEMED AS REPORTABLE BASED ON A CLINICAL IMPACT ASSESSMENT DATE OF (B)(6) 2023.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16448587 ↗
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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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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