WEST PHARMA. SERVICES IL, LTD recalls Vial2BAG DC 13mm, REF 6070111, Single use only, Rx Only

Recall date

December 26, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0767-2019

FDA classification

Class I

Brand / firm

WEST PHARMA. SERVICES IL, LTD

Sold / distributed

US Distributor in MO

Why it was recalled

Adverse events have been reported with the use of oxytocin in conjunction with the product in pregnant women. There is a possibility that the device may cause inadequate admixing of drug with the solution in the IV bag. This could lead to concentrated drug pooling in the device and bolus injections.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Vial2BAG DC 13mm, REF 6070111, Single use only, Rx Only