# FDA recall Z-0769-2019

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

## Product

Vial2BAG DC 20mm:  1) REF 6070112 & 2) REF 6070112C, Single use only, Rx Only

## Reason for recall

Adverse events have been reported with the use of oxytocin in conjunction with the 13mm Vial2Bag DC in pregnant women. Vial2Bag DC 20mm is recalled due to similarities with 13mm Vial2Bag DC.

## Distribution

US Distributor in MO

## Key facts

- **Recall number:** Z-0769-2019
- **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-0769-2019

## Citation

> AI Analytics. FDA recall Z-0769-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0769-2019. Source: US FDA. Licensed CC0.

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