Class I designations, the FDA’s most severe, are used when there is a reasonable probability that product use could cause serious adverse health consequences of death.
The West Whiteland Township, Penn.-based company’s Vial2Bag fluid transfer systems are designed to connect a vial containing medication to an intravenous therapy bag to aid in mixing the medication with the IV fluids, according to an FDA release.
The company is recalling the devices due to a possibility that the systems may not adequately transfer concentrated medications from the vial to the IV bag prior to patient infusion.
“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 agency wrote in its posting.
The federal watchdog said that it has received 16 complaints of serious adverse health related consequences related to the use of the 13mm device with oxytocin in pregnant women during labor and delivery.
As the device can be used with a variety of different medications under different patient settings, the FDA said that all Vial2Bag systems are being recalled during an investigation of the issues.
The recall affects approximately 38.8 million Vial2Bag Direct Connect 13mm and 20mm and Vial2Bag devices with model numbers 6070104, 6070111 and 6070112 manufactured between February 9, 2016 and January 1, 2019 and distributed between March 15, 2016 and January 8, 2019, according to the release.
West Pharma began notifying customers of the issues late last month, and instructed them to immediately discontinue use and quarantine affected devices.
Last month, Drug Delivery Business News spoke to West global biologics biz VP Cindy Reiss-Clark on the drug delivery trends that stood out in 2018 and what could be coming during 2019.