West Pharmaceutical Services Inc. Recalls Vial2Bag Fluid Transfer Systems Due to Potential Malfunctions

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled Product(s): Vial2Bag Direct Connect (DC) 13mm and 20mm, & Vial2Bag
Model Numbers: 6070104, 6070111, 6070112
Manufacturing Dates: February 9, 2016, to January 1, 2019
Distribution Dates: March 15, 2016, to January 8, 2019
Devices Recalled in the U.S.: 38.8 million units nation wide

Device Use

The Vial2Bag fluid transfer systems are used to connect a vial containing medication to an intravenous (IV) therapy bag and to aid in mixing the medication with the fluid in the IV bag.

Reason for Recall

West Pharmaceutical Services Inc. is recalling the Vial2Bag fluid transfer systems due to the possibility that the device may not adequately transfer concentrated medication from a vial to an IV bag before infusion into a patient's vein. If inadequate transfer occurs, the drug delivered to the patient may have variable or unpredictable dosing, which means that a patient may be infused with an overdose or under-dose of medication, leading to life-threatening adverse health consequences.

The FDA received sixteen complaints of serious adverse health consequences related to the use of the 13mm device with oxytocin in pregnant women in connection with labor and delivery. Since this device may be used with many different types of medications in different patient care settings, all the Vial2Bag fluid transfer systems are being recalled while an investigation is underway.

Who May be Affected

Patients receiving IV medication that was transferred from a medication vial to an IV infusion bag using a Vial2Bag device
Hospitals and health care professionals using the Vial2Bag devices to transfer medication from vials to IV bags for infusion

What to Do

On January 23, 2019, West Pharmaceutical Services Inc. sent customers and distributors an "Amended Urgent Medical Device Recall" notice with the following instructions.

Customers:
- Immediately discontinue use of the device, remove it from your inventory, and quarantine the product to prevent inadvertent use;
- Contact Progressive Medical Inc. (PMI), 997 Horan Drive Fenton, Missouri 63026-2401, or at 1-800-969-6331, 8am to 5pm, Central Time, Monday through Friday to schedule return of affected products.
- Complete and return the Recall Acknowledgement and Receipt Form attached to the notice to Linda Bagby at cs@progressivemedinc.com; and to
- Rely on current standard of practice of medicine for admixing medications for IV therapy.
Distributors:
- Examine your inventory and quarantine all products subject to the recall;
- Identify customers you sent the products to;
- Notify and provide the "Amended Urgent Medical Device Recall" notice to all customers affected;
- Follow up with customers to locate and establish the number of units affected in their possession; and to
- Complete and return the Recall Acknowledgement and Receipt Form attached to the notice to recall@westpharma.com.

Contact Information

Customers who have questions or need additional information regarding this recall may contact Progressive Medical Inc. at 1-800-969-6331, 8am to 5pm, Central Time, Monday through Friday.

Date Recall Initiated

December 12, 2018

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program. Health care professionals employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.