Vial2BAG DC 13mm, REF 6070111, Single use only, Rx Only
Check against the official notice below — it lists the full affected range.
West Pharma. Services IL, LTD has recalled approximately 3.9 million units of Vial2BAG DC 13mm devices (a single-use, prescription medical device) due to adverse events reported when the product is used with oxytocin in pregnant women. The device may fail to properly mix the drug with the intravenous solution, potentially causing the drug to pool in concentrated amounts within the device and be delivered to patients as sudden bolus injections rather than as a controlled infusion.
The recalled devices were distributed in the United States through a Missouri distributor and include specific lot numbers ranging from 7153 through A839. The source document does not specify what actions affected consumers should take regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: US Distributor in MO Quantity: 3.9 million units Lot/code info: UDI: (01)07290108240061(17)211031(10)A839(90)3609812 5(91)6070111 Lot Numbers: 7153, 7154, 7634, 7688, 7752, 7909, 7955, 8152, 8153, 8154, 8232, 8233, 8234, 8235, 9028, 9175, 9029, 9176, 9177, 9178, 9367, 9368, 9369, 9370, 9654, 9656, 9655, 9918, 9710, 9711, 9712, 9713, 9839, 9840, 9983, 9984, 9992, 9993, 9994, 9995, A123, A124, A790, A805, A806, A791, A792, A793, A794, A795, A796, A797, A807, A808, A809, A810, A834, A835, A836, A837, A838 & A839
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.