Z-0283-2025Class II

Brand Name: Vial2Bag Advanced Product Name: Vial2Bag Advanced 20mm Admixture Device Model/Catalog Number...

Name: Z-0283-2025 Brand Name: Vial2Bag Advanced Product Name: Vial2Bag Advanced 20mm Admixture Device Model/Catalog Number...
Creator: West Pharmaceutical Services AZ, Inc.
Published: 2024-09-24
License: https://open.fda.gov/license/

West Pharmaceutical Services AZ, Inc. / initiated 2024-09-24 / Open, Classified / root cause: manufacturing process

FDA source

West Pharmaceutical Services AZ, Inc. began a recall of Brand Name: Vial2Bag Advanced Product Name: Vial2Bag Advanced 20mm Admixture Device Model/Catalog Number: 6070030 Software Version: Not applicable Product... on 2024-09-24. FDA classified it as Class II and gives the reason as "Due to packaging damage from heat exposure during shipping/transportation that may result in a breach in the sterile barrier". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0283-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-09-24
Posted: 2024-11-01
Recalling firm: West Pharmaceutical Services AZ, Inc.
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
Product code: LHI Set, I.V. Fluid Transfer
Reason for recall: Due to packaging damage from heat exposure during shipping/transportation that may result in a breach in the sterile barrier.
Root cause tag: manufacturing process
FDA root 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 [email protected] 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 [email protected] 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 [email protected]
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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0283-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0283-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-06	2024-10-31

Product code LHI

K201415Class IIVial2Bag Advanced 20mm Admixture DeviceWest Pharmaceutical Services Az, Inc. / cleared 2020-10-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)