FDA-Device2019-02-06Class I
Vial2BAG DC 13mm, REF 6070111, 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 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.
Sold states
US Distributor in MO
Affected count
3.9 million units
Manufactured in
4, Ha-Sheizaf, N/A, Ra'Anana, N/A, Israel
Products
Vial2BAG DC 13mm, REF 6070111, Single use only, Rx Only
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0767-2019Don't want to check this manually?
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