Medical Device Recall: 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
West Pharmaceutical Services AZ, Inc. · September 24, 2024
Reason for Recall
Due to packaging damage from heat exposure during shipping/transportation that may result in a breach in the sterile barrier.
Product Description
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
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.
States Affected
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 Affected
129600
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0283-2025
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.