FDA Device recall Z-0767-2019
Vial2BAG DC 13mm, REF 6070111, Single use only, Rx Only
- FDA Device
- Class I
- terminated
- Published 2019-02-06
On 2019-02-06 the FDA classified a Class I recall of Vial2BAG DC 13mm, REF 6070111, Single use only, Rx Only by West Pharma Services Il, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0767-2019 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2018-12-26 |
| Published | 2019-02-06 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | West Pharma Services Il |
| Distribution | MO |
Product
Vial2BAG DC 13mm, REF 6070111, Single use only, Rx Only
Reason
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.
Identifiers
| code_info | UDI: (01)07290108240061(17)211031(10)A839(90)3609812 5(91)6070111 Lot Numbers: 7153, 7154, 7634, 7688, 7752, 7909,…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 history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0767-2019%22
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