Medimop Medical Projects Ltd. recalls Vial2BagDC, Product Number 6070112. The 20mm Vial2Bag DC device, is intended for use in healthcare facilities or in-hom…

Recall date

October 6, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0972-2018

FDA classification

Class II

Brand / firm

Medimop Medical Projects Ltd.

Sold / distributed

US Distribution

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.