WEST PHARMA. SERVICES IL, LTD recalls Vial2BAG Transfer Device, REF 6070104, Single use only, Rx Only

Recall date

December 26, 2018

Source

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

Recall number

Z-0768-2019

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 13mm Vial2Bag DC in pregnant women. Vial2Bag is recalled due to similarities with 13mm Vial2Bag DC.

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 Transfer Device, REF 6070104, Single use only, Rx Only