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FDADecember 26, 2018device

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

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

west pharma services ilwestwest pharma

UPCs

07290108240061

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Vial2BAG DC 13mm, REF 6070111, Single use only, Rx Only — Recall Details · AllClear