Recall Z-0972-2018— Medimop Medical Projects Ltd.
Class II · Terminated
Class II FDA medical device recall by Medimop Medical Projects Ltd., initiated 2017-10-06, terminated 2024-01-23. It names 2 FDA 510(k) clearances: K170095, K140730. 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: 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..
- Recalling firm
- Medimop Medical Projects Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-10-06
- Terminated
- 2024-01-23
- Firm location
- Raanana, Israel
510(k) clearances named in this recall
2 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.