FDA-Device2018-03-21Class II
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.
Medimop Medical Projects Ltd.
Hazard
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.
Sold states
US Distribution
Affected count
453,600 units
Manufactured in
4 Hayetzira Street,, P.O. Box 2499, Raanana, Israel
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0972-2018Don't want to check this manually?
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