Class 2 Device Recall Vial2Bag Advanced

• Date Initiated by Firm: September 24, 2024
• Date Posted: November 01, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0283-2025
• Recall Event ID: 95449
• 510(K)Number: K201415
• Product Classification: Set, i.V. Fluid transfer - Product Code LHI
• 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
• Code Information: 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
• Recalling Firm/ Manufacturer: West Pharmaceutical Services AZ, Inc.; 7400 E Tierra Buena Ln Ste 101; Scottsdale AZ 85260-1795
• For Additional Information Contact: Michele Polinsky; 1-610-8503279
• Manufacturer Reason for Recall: Due to packaging damage from heat exposure during shipping/transportation that may result in a breach in the sterile barrier.
• FDA Determined Cause: Environmental control
• Action: 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
• Quantity in Commerce: 129600
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = LHI