Vial2BAG DC 13mm, REF 6070111, Single use only, Rx Only
FDA Recall #Z-0767-2019 — Class I — December 26, 2018
Product Description
Vial2BAG DC 13mm, REF 6070111, Single use only, Rx Only
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.
Recalling Firm
WEST PHARMA. SERVICES IL, LTD — Ra'Anana, N/A
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
3.9 million units
Distribution
US Distributor in MO
Code Information
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated