# FDA recall Z-0767-2019

> **WEST PHARMA. SERVICES IL, LTD** · Class I · device recall initiated 2018-12-26.

## 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.

## Distribution

US Distributor in MO

## Key facts

- **Recall number:** Z-0767-2019
- **Recalling firm:** WEST PHARMA. SERVICES IL, LTD
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-12-26
- **Report date:** 2019-02-06
- **Termination date:** 2022-07-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Ra'Anana, N/A, Israel

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0767-2019

## Citation

> AI Analytics. FDA recall Z-0767-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0767-2019. Source: US FDA. Licensed CC0.

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