Z-0767-2019 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 6, 2019
- Initiation Date
- December 26, 2018
- Termination Date
- July 20, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3.9 million units
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.
Distribution Pattern
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