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
- Recall Initiated
- September 24, 2024
- Posted
- November 1, 2024
- Recall Number
- Z-0283-2025
- Quantity
- 129600
- Firm Location
- Scottsdale, AZ
Reason for Recall
Due to packaging damage from heat exposure during shipping/transportation that may result in a breach in the sterile barrier.
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.
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
Root Cause
Environmental control
Action Taken
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