Ra'Anana, N/A, Israel
WEST PHARMA. SERVICES IL, LTD recalls
1 recall recorded since 2018, most recently on 26 December 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)1
Terminated Class I Medical devices
- Recall started
- 26 December 2018
- Terminated
- 20 July 2022
- 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.
- Distribution
- US Distributor in MO
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0767-2019, Z-0769-2019, Z-0768-2019
- Vial2BAG DC 13mm, REF 6070111, Single use only, Rx Only
- Vial2BAG DC 20mm: 1) REF 6070112 & 2) REF 6070112C, Single use only, Rx Only
- Vial2BAG Transfer Device, REF 6070104, Single use only, Rx Only
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.