FDA-Device2019-02-06Class I

Vial2BAG Transfer Device, REF 6070104, Single use only, Rx Only

WEST PHARMA. SERVICES IL, LTD
Hazard

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.

Sold states
US Distributor in MO
Affected count
4.9 million units
Manufactured in
4, Ha-Sheizaf, N/A, Ra'Anana, N/A, Israel
Products
Vial2BAG Transfer Device, REF 6070104, Single use only, Rx Only

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0768-2019

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