# FDA recall Z-0283-2025

> **West Pharmaceutical Services AZ, Inc.** · Class II · device recall initiated 2024-09-24.

## Product

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 devic

## Reason for recall

Due to packaging damage from heat exposure during shipping/transportation that may result in a breach in the sterile barrier.

## Distribution

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.

## Key facts

- **Recall number:** Z-0283-2025
- **Recalling firm:** West Pharmaceutical Services AZ, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-09-24
- **Report date:** 2024-11-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Scottsdale, AZ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0283-2025

## Citation

> AI Analytics. FDA recall Z-0283-2025. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-0283-2025. Source: US FDA. Licensed CC0.

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