Class I Recall of West Pharmaceutical Services Inc. Vial2Bag Fluid Transfer Systems
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 U.S. Food and Drug Administration (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.
Recalled Product Details:
- 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
On January 23, 2019, West Pharmaceutical Services Inc. sent customers and distributors an "Amended Urgent Medical Device Recall" notice with the following instructions.
- 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@example.com; and to
- Rely on current standard of practice of medicine for admixing medications for IV therapy.
- 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 firstname.lastname@example.org.
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.
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