Vial2Bag Advanced (West Pharmaceutical) – Packaging Damage (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
West Pharmaceutical Services AZ, Inc.
Lot Codes / Batch Numbers
Lot Code: Recall Product 1: Product Code 6080030, Lot# K188, Lot# K194, UDI (01)10850022888011(17)270430(10)K194\F(90)36098150\F(91)6070030
Products Sold
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
West Pharmaceutical Services AZ, Inc. is recalling Brand Name: Vial2Bag Advanced Product Name: Vial2Bag Advanced 20mm Admixture Device Model/Catalog Nu due to Due to packaging damage from heat exposure during shipping/transportation that may result in a breach in the sterile barrier.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to packaging damage from heat exposure during shipping/transportation that may result in a breach in the sterile barrier.
Recommended Action
Per FDA guidance
On 09/24/2024, the firm emailed an "URGENT: MEDICAL DEVICE RECALL" Letter informing customers that due to possible package damage during shipping and transportation, which may result in breach in sterile barrier that compromises the safety and efficacy of the devices. Distributor are instructed to: 1. Examine their inventory and quarantine Affected Product subject to this voluntary recall. 2. If the Affected Product was distributed to additional customers, send them this letter. 3. Follow up with each account/customer to locate and identify all Affected Product in Appendix 1 and establish the number of units of Affected Product in possession of each account/customer. 4. Complete the Recall Acknowledgement and Receipt Form below and return (via email) to recall@westpharma.com when complete responses are available (See attached form). Customers/Users are instructed to: 1. If they have any Affected Product in their inventory, immediately discontinue use, remove it from inventory and quarantine the product to prevent inadvertent use. 2. Contact Progressive Medical Inc. (PMI), 997 Horan Drive Fenton, Missouri 63026-2401 to schedule return of Affected Products. x 1-800-969-6331; 8am to 5pm, Central Time, Monday through Friday 3. Complete the Recall Acknowledgement and Receipt Form and return to Linda Bagby by email at cs@progressivemedinc.com within 5 days, even if customers no longer have any Affected Product in their possession (See attached form). This will allow West to document receipt of this letter. For questions or assistance - contact West's U.S. distributor Progressive Medical Inc at 1-800-969-6331, 8am to 5pm Central Time Monday thru Friday or as cs@progressivemedinc.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
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
Page updated: Jan 10, 2026