West Pharmaceutical Services 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 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.
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.
On January 23, 2019, West Pharmaceutical Services 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 [email protected]; 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 [email protected].