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WEST PHARMA. SERVICES IL, LTD recalls Vial2BAG DC 13mm, REF 6070111, Single use only, Rx Only
Recalled February 6, 2019 · FDA recall Z-0767-2019 · WEST PHARMA. SERVICES IL
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. · FDA Class I
Units
3.9 million units
Sold at
US Distributor in MO
Description
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.
Product
Vial2BAG DC 13mm, REF 6070111, Single use only, Rx Only
Manufacturer(s)
WEST PHARMA. SERVICES IL, LTD
Made in
Israel
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →