The United States Food and Drug Administration (FDA) has issued a medical device safety alert concerning Vial2Bag Direct Connect (DC) 13mm and 20mm, & Vial2Bag [Model Number: 6070104, 6070111, 6070112; Manufacturing Date: 9 February 2016 to 1 January 2019], manufactured by West Pharmaceutical Services Inc.
The manufacturer 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.
According to the FDA, it 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 the 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.
The manufacturer has sent affected customers an "Amended Urgent Medical Device Recall" notice with the following instructions:
Product recall is on-going.
For details, please refer to the following FDA website:
https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm630325.htm
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 04 February 2019