Vial2Bag Advanced Admixture Devices Recalled for Sterile Barrier Breach

Agency Publication Date: November 1, 2024

Summary

West Pharmaceutical Services is recalling 129,600 units of the Vial2Bag Advanced 20mm Admixture Device. The recall is due to packaging damage from heat exposure during shipping that may have broken the sterile barrier. These single-use devices are used by healthcare providers to transfer medications from drug vials into IV bags. While no injuries or incidents have been reported, a broken sterile seal can lead to contamination of the medical fluids.

Risk

If the packaging is damaged, the device may no longer be sterile. Using a non-sterile device to prepare IV medications can introduce bacteria or other contaminants directly into a patient's bloodstream, potentially causing serious infections or health complications.

What You Should Do

This recall affects the Vial2Bag Advanced 20mm Admixture Device, specifically catalog number 6070030 and product code 6080030.
Identify the affected products by checking for Lot numbers K188 or K194 on the device packaging or label. See the Affected Products section below for the specific UDI codes associated with these lots.
Stop using the recalled device immediately and quarantine any remaining stock from the affected lots.
Contact the manufacturer, West Pharmaceutical Services AZ, Inc., or your distributor, Progressive Medical Inc. (PMI), to arrange for the return, replacement, or correction of the devices.
Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this recall.

Your Remedy Options

Other Action

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Vial2Bag Advanced 20mm Admixture Device

Variants: Single use, Sterile, Non-pyrogenic

Model / REF:

6070030

6080030

Lot Numbers:

K188

K194

UDI:

10850022888011

UDI Strings: (01)10850022888011(17)270430(10)K188 and (01)10850022888011(17)270430(10)K194

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95449

Status: Active

Manufacturer: West Pharmaceutical Services AZ, Inc.

Sold By: Progressive Medical Inc. (PMI); Hospitals

Manufactured In: United States

Units Affected: 129600

Distributed To: Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Washington, Wisconsin

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects the Vial2Bag Advanced 20mm Admixture Device, specifically catalog number 6070030 and product code 6080030.

Identify the affected products by checking for Lot numbers K188 or K194 on the device packaging or label. See the Affected Products section below for the specific UDI codes associated with these lots.

Stop using the recalled device immediately and quarantine any remaining stock from the affected lots.

Contact the manufacturer, West Pharmaceutical Services AZ, Inc., or your distributor, Progressive Medical Inc. (PMI), to arrange for the return, replacement, or correction of the devices.

Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this recall.