CLASS II ONGOING Device recall · Reported 6 Nov 2024 · FDA Enforcement Report
Vial2Bag Advanced¿ Admixture Device recalled
West Pharmaceutical Services AZ is recalling Vial2Bag Advanced¿ Admixture Device, distributed in 33 states. The recall was initiated on 24 Sep 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0283-2025
- FDA event ID
- 95449
- Recalling firm
- West Pharmaceutical Services AZ, Scottsdale, AZ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 Sep 2024
- FDA classified
- 31 Oct 2024
- Reported
- 6 Nov 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Infusion Pumps
Timeline
| 24 Sep 2024 | Recall initiated by company | |
| 31 Oct 2024 | Classified by FDA | +37 days |
| 6 Nov 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to packaging damage from heat exposure during shipping/transportation that may result in a breach in the sterile barrier.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Brand Name: Vial2Bag Advanced¿ Product Name: Vial2Bag Advanced¿ 20mm Admixture Device Model/Catalog Number: 6070030 Software Version: Not applicable Product Description: The Vial2Bag Advanced 20mm Admixture Device is a single use, fluid transfer device that allows for the reconstitution and transfer of fluids from drug vials into the IV bag containing infusion solution, through the IV bag administration port. The device consists of the body, Protector, IV Port, and an integrated vial adapter. The device is provided as a sterile, non-pyrogenic product. The device is intended to be used with standard drug vials with a seal diameter of 20mm and an elastomeric stopper. The Vial2Bag Advanced 20mm Admixture Device is designed to work with a standard 50, 100, or 250mL IV bag and an external IV administration set. The device does not contain any medicinal substances and there are no additional accessories needed or provided with the Vial2Bag Advanced 20mm Admixture Device for the device to meet its intended purpose. Component: No
Where it was distributed
A U.S. Distributor, Progressive Medical Inc. (PMI) currently supplies the Vial2Bag Advanced 20mm Admixture Device to hospitals in the U.S. (end user). PMI distributed the impacted Vial2Bag Advanced 20mm Admixture Device lots to the end users. U.S.: Distributor located in MO U.S. Customers: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KY, LA, MD, MI, MN, MO, MS, NC, NE, NM, NV, NY, OH, OK, OR, PA,SC, TN, TX, UT, WA, and WI.
AlabamaArkansasArizonaCaliforniaColoradoConnecticutFloridaGeorgiaHawaiiIllinoisIndianaKentuckyLouisianaMarylandMichiganMinnesotaMissouriMississippiNorth CarolinaNebraska
Questions about this recall
Why was it recalled?
Due to packaging damage from heat exposure during shipping/transportation that may result in a breach in the sterile barrier.
Which lots are affected?
Lot Code: Recall Product 1: Product Code 6080030, Lot# K188, UDI (01)10850022888011(17)270430(10)K188\F(90)36098150\F(91)6070030 Recall Product 2: Product Code 6080030, Lot# K194, UDI (01)10850022888011(17)270430(10)K194\F(90)36098150\F(91)6070030
Where was it sold?
A U.S. Distributor, Progressive Medical Inc. (PMI) currently supplies the Vial2Bag Advanced 20mm Admixture Device to hospitals in the U.S. (end user). PMI distributed the impacted Vial2Bag Advanced 20mm Admixture Device lots to the end users. U.S.: Distributor located in MO U.S. Customers: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KY, LA, MD, MI, MN, MO, MS, NC, NE, NM, NV, NY, OH, OK, OR, PA,SC, TN, TX, UT, WA, and WI.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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| Device | CLASS II | Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
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