Brand Name: Vial2Bag Advanced¿ Product Name: Vial2Bag Advanced¿ 20mm… — Class II medical device recall Z-0283-2025
Ongoing recall by West Pharmaceutical Services AZ, Inc., reported 2024-11-06, distributed in AL, AR, AZ, CA, CO, CT, FL, GA…. Due to packaging damage from heat exposure during shipping/transportation that may result in a breach in the s
| Recall number | Z-0283-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | West Pharmaceutical Services AZ, Inc., Scottsdale, AZ, United States |
| Recall initiated | 2024-09-24 |
| Classified | 2024-10-31 |
| Reported by FDA | 2024-11-06 |
| Distributed | 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, WI |
| Quantity | 129,600 |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10850022888011 |
| Lot numbers | K188, K194 |
| Model numbers | 6070030 |
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 device to meet its intended purpose. Component: No
Reason for recall
Due to packaging damage from heat exposure during shipping/transportation that may result in a breach in the sterile barrier.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0283-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.