Medical Device Recall : West Pharmaceutical Services Inc. Recalls Vial2Bag Fluid Transfer Systems

West Pharmaceutical recalls Vial2Bag

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• 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.