FDA recall Z-0972-2018

Product

Vial2BagDC, Product Number 6070112. The 20mm Vial2Bag DC device, is intended for use in healthcare facilities or in-home environment by the patient or care-giver to aid and support prescribed treatment and therapy. The device consists of the Vial2Bag piercing spike and cover, the IV Port connector and an integrated Vial Adapter (20mm) for access to the drug/solution vial.

Reason for recall

Medimop is recalling certain lots of this product Vial2Bag DC due to the potential of the IV Port separating from the Via12Bag DC body during the drug reconstitution I IV Set attachment process.

Distribution

US Distribution

Key facts

Status

Terminated

Initiation date

2017-10-06

Report date

2018-03-21

Termination date

2024-01-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Raanana, Israel

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0972-2018