FDA recall Z-0768-2019

WEST PHARMA. SERVICES IL, LTD · Class I · device

Product

Vial2BAG Transfer Device, REF 6070104, 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 is recalled due to similarities with 13mm Vial2Bag DC.

Distribution

US Distributor in MO

Key facts

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

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0768-2019