medical Class II Updated 2024-11-06

West Pharmaceutical Services AZ, Inc. recalls Brand Name: Vial2Bag Advanced¿ Product Name: Vial2Bag Advan

Recalled 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

Hazard / Issue

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

Issued by

FDA

Affected States: MO, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KY, LA, MD, MI, MN, MS, NC, NE, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, WA, WI
Lot/Code Info: 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
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