FDA recall Z-0767-2019

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

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-0767-2019