Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Brand Name: Vial2Bag Advanced¿ Product Name: Vial2Bag Advanced¿ 20mm Admixture Recalled by West Pharmaceutical Services AZ, Inc. Due to Due to packaging damage from heat exposure during...

Date: September 24, 2024
Company: West Pharmaceutical Services AZ, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact West Pharmaceutical Services AZ, Inc. directly.

Affected Products

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

Quantity: 129600

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 33 states: AL, AZ, AR, CA, CO, CT, FL, GA, HI, IL, IN, KY, LA, MD, MI, MN, MS, MO, NE, NV, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, WA, WI

Affected (33 states)Not affected

About West Pharmaceutical Services AZ, Inc.

West Pharmaceutical Services AZ, Inc. has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report