Vial2BAG DC 13mm — Class I medical device recall Z-0767-2019
Terminated recall by WEST PHARMA. SERVICES IL, LTD, reported 2019-02-06. Adverse events have been reported with the use of oxytocin in conjunction with the product in pregnant women.
| Recall number | Z-0767-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | WEST PHARMA. SERVICES IL, LTD, Ra'Anana, N/A, Israel |
| Recall initiated | 2018-12-26 |
| Classified | 2019-01-28 |
| Reported by FDA | 2019-02-06 |
| Terminated | 2022-07-20 |
| Quantity | 3.9 million |
| UPC / GTIN / UDI-DI | 07290108240061 |
| Lot numbers | 7153, 7154, 7634, 7688, 7752, 7909, 7955, 8152, 8153, 8154, 8232, 8233, 8234, 8235, 9028, 9029, 9175, 9176, 9177, 9178, 9367, 9368, 9369, 9370, 9654, 9655, 9656, 9710, 9711, 9712, 9713, 9839, 9840, 9918, 9983, 9984, 9992, 9993, 9994, 9995 and 22 more |
| Model numbers | 6070111 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0767-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.