FDA recall Z-0769-2019

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

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-0769-2019